Conectar
Decisions regarding the optimal timing of intervention for asymptomatic aortic stenosis (AS) are controversial. The study aims to identify potential risk factors for asymptomatic patients with severe AS that are associated with worse prognosis and to evaluate the benefits of early interventions for asymptomatic patients presenting with one or more additional risk factors.
This is a non-interventional, prospective, open-label, multicentre registry study across China. A total of 1000 patients will be enrolled and categorised as symptomatic or asymptomatic. The primary endpoint is the occurrence of all-cause mortality, stroke, acute myocardial infarction and heart failure-related hospitalisation at 1-year follow-up. In asymptomatic severe AS patients presenting with one or more risk factors, the occurrence rate of the primary endpoint between those who undergo transcatheter aortic valve replacement (TAVR) and those who do not will be compared. We will also compare the occurrence rate of the primary endpoint for asymptomatic severe AS patients with additional risk factors who undergo TAVR with those presenting with symptoms. This study is believed to provide additional evidence to help clinicians identify and refer severe AS patients who are asymptomatic but present with additional risk factors for early intervention of TAVR.
The study protocol has been approved by the local ethics committee of each participating site: West China Hospital, Sichuan University; Sir Run Run Shaw Hospital, Zhejiang University School of Medicine; Second Hospital of Hebei Medical University; Tianjin Chest Hospital; and First Affiliated Hospital of Nanchang University. All participants will provide written informed consent. Study results will be published through academic conferences and peer-reviewed journals.
This study was registered at the Chinese Clinical Trial Registry (https:// www.chictr.org.cn), with the registration number ChiCTR2200064853.
Compared with ST-segment elevation myocardial infarction (STEMI) patients, non-STEMI (NSTEMI) patients have more comorbidities and extensive coronary artery disease. Contemporary comparative data on the long-term prognosis of stable post-myocardial infarction subtypes are needed.
Long-Term rIsk, clinical manaGement and healthcare Resource utilisation of stable coronary artery dISease (TIGRIS) was a multinational, observational and longitudinal cohort study.
Patients were enrolled from 350 centres, with >95% coming from cardiology practices across 24 countries, from 19 June 2013 to 31 March 2017.
This study enrolled 8277 stable patients 1–3 years after myocardial infarction with ≥1 additional risk factor.
Over a 2 year follow-up, cardiovascular events and deaths and self-reported health using the EuroQol 5-dimension questionnaire score were recorded. Relative risk of clinical events and health resource utilisation in STEMI and NSTEMI patients were compared using multivariable Poisson regression models, adjusting for prognostically relevant patient factors.
Of 7752 patients with known myocardial infarction type, 46% had NSTEMI; NSTEMI patients were older with more comorbidities than STEMI patients. NSTEMI patients had significantly poorer self-reported health and lower prevalence of dual antiplatelet therapy at hospital discharge and at enrolment 1–3 years later. NSTEMI patients had a higher incidence of combined myocardial infarction, stroke and cardiovascular death (5.6% vs 3.9%, p
Post-NSTEMI chronic coronary syndrome patients had a less favourable risk factor profile, poorer self-reported health and more adverse cardiovascular events during long-term follow-up than individuals post STEMI. Efforts are needed to recognise the risks of stable patients after NSTEMI and optimise secondary prevention and care.
The relevance of measures of general and central adiposity for cardiovascular disease (CVD) risks in populations of European descent is well established. However, it is less well characterised in South Asian populations, who characteristically manifest larger waist circumferences (WC) for equivalent body mass index (BMI). This systematic review and meta-analysis provide an overview of the literature on the association of different anthropometric measures with CVD risk among South Asians.
MEDLINE and Embase were searched from 1990 to the present for studies in South Asian populations investigating associations of two or more adiposity measures with CVD. Random-effects meta-analyses were conducted on the associations of BMI, WC and waist-to-hip ratio (WHR) with blood pressure, hypertension and CVD. Quality assessment was performed using the Newcastle-Ottawa scale.
Titles and abstracts were screened for 7327 studies, yielding 147 full-text reviews. The final sample (n=30) included 2 prospective, 5 case-control and 23 cross-sectional studies. Studies reported generally higher risks of hypertension and CVD at higher adiposity levels. The pooled mean difference in systolic blood pressure (SBP) per 5 kg/m2 higher BMI was 3 mmHg (2.90 (95% CI 1.30 to 4.50)) and 6 mmHg (6.31 (95% CI 4.81 to 7.81) per 13 cm larger WC. The odds ratio (OR) of hypertension per 5 kg/m2 higher BMI was 1.33 (95% CI 1.18 to 1.51), 1.45 (95% CI 1.05 to 1.98) per 13 cm larger WC and 1.22 (95% CI 1.04 to 1.41) per 0.1-unit larger WHR. Pooled risk of CVD for BMI-defined overweight versus healthy-weight was 1.65 (95% CI 1.55 to 1.75) and 1.48 (95% CI 1.21 to 1.80) and 2.51 (95% CI 0.94 to 6.69) for normal versus large WC and WHR, respectively. Study quality was average with significant heterogeneity.
Measures of both general and central adiposity had similar, strong positive associations with the risk of CVD in South Asians. Larger prospective studies are required to clarify which measures of body composition are more informative for targeted CVD primary prevention in this population.
To explore the association between non-high-density lipoprotein (non-HDL) and mortality risk, both short-term and long-term, in Chinese people.
A prospective cohort study.
The National Basic Public Health Service (BPHS) in China.
Including 621 164 elderly individuals around Hunan Province who underwent healthcare management receiving check-ups in China BPHS from 2010 to 2020. Exclusion criteria: (1) missing information on gender; (2) missing records of lipid screening; (3) missing information on key covariates; and (4) missing records of comorbidities (cardiovascular disease, hypertension, diabetes, cancer.)
The study’s primary endpoint was all-cause and cause-specific mortality, sourced from Hunan’s CDC(Center for Disease Control and Prevention)-operated National Mortality Surveillance System, tracking participants until 24 February 2021.
26 758 (4.3%) deaths were recorded, with a median follow-up of 0.83 years. Association between non-HDL and mortality was non-linear after multivariable adjustment, with the optimum concentration (OC) being 3.29 and 4.85 mmol/L. Compared with OC, the risk increased by 1.12-fold for non-HDL for non-HDL : 1.10 (1.06 to 1.32) and HR for non-HDL ≥4.85: 1.07 (1.01 to 1.14)). However, cancer mortality risk was significantly increased only for non-HDL
Non-HDL was non-linearly associated with the risk of mortality, and non-optimal concentrations of non-HDL significantly increased short-term mortality in elderly Chinese, which needs more attention for cardiovascular disease prevention.
Today, the involvement of patients in their care is essential. As the population ages increases, the number of patients with chronic diseases is increasing. In the vascular medicine and surgery departments, patients are polymedicated and mostly suffer from several chronic diseases. Approximately 50% of patients with a chronic disease are not adherent. Among the factors that can influence therapeutic adherence are the beliefs and representations of patients.
To evaluate the beliefs and representations of chronic treatments in patients with multiple medications and hospitalised in a vascular medicine and surgery department, and to evaluate the medication adherence, the knowledge and the importance patients attach to their treatments.
Observational, prospective and a single-centre study.
The study was conducted in a French tertiary hospital centre of around 3000 beds in 9 institutions.
Adult polymedicated (ie, minimum of five chronic treatments) patients hospitalised in a vascular medicine and surgery department were included after application of the exclusion criteria.
Patient interviews were carried out in the department and were based on three interviewer-administered questionnaires (a global questionnaire, the Belief Medical Questionnaire and the GIRERD questionnaire).
Our study showed that patients perceived their treatments as beneficial rather than worrying. A correlation between medication adherence and beliefs was observed. ‘Non-adherent’patients had a more negative overall view of medication than ‘adherent’ patients. The level of compliance and knowledge of our patients was low. Only 11% of the patients were ‘good adherent’, 16% of the patients could perfectly name their treatment and 36% knew all the indications.
Knowledge of treatment representation and beliefs are central to understanding patient behaviour. Considering patients’ representations will allow the identification of levers, and the development of actions and educational tools adapted to improve their adherence, their knowledge and therefore their drug management.
Patients diagnosed with coronary artery disease (CAD) are currently treated with medications and lifestyle advice to reduce the likelihood of disease progression and risk of future major adverse cardiovascular events (MACE). Where obstructive disease is diagnosed, revascularisation may be considered to treat refractory symptoms. However, many patients with coexistent cardiovascular risk factors, particularly those with metabolic syndrome (MetS), remain at heightened risk of future MACE despite current management.
Cardiac rehabilitation is offered to patients post-revascularisation, however, there is no definitive evidence demonstrating its benefit in a primary prevention setting. We propose that an intensive lifestyle intervention (Super Rehab, SR) incorporating high-intensity exercise, diet and behavioural change techniques may improve symptoms, outcomes, and enable CAD regression.
This study aims to examine the feasibility of delivering a multicentre randomised controlled trial (RCT) testing SR for patients with CAD, in a primary prevention setting.
This is a multicentre randomised controlled feasibility study of SR versus usual care in patients with CAD. The study aims to recruit 50 participants aged 18–75 across two centres. Feasibility will be assessed against rates of recruitment, retention and, in the intervention arm, attendance and adherence to SR. Qualitative interviews will explore trial experiences of study participants and practitioners. Variance of change in CAD across both arms of the study (assessed with serial CT coronary angiography) will inform the design and power of a future, multi-centre RCT.
Ethics approval was granted by South West—Frenchay Research Ethics Committee (reference: 21/SW/0153, 18 January 2022). Study findings will be disseminated via presentations to relevant stakeholders, national and international conferences and open-access peer-reviewed research publications.
Hypertension is one of the most serious global health problems, and its prevention and treatment mainly rely on lifestyle intervention and medication. However, the current situation of hypertension control in China is still not ideal. Self-monitoring of blood pressure is expected to be a new way to control hypertension. Intervention and the Intelligent Hypertension Management System (IHMS), an information platform relying on the network and smartphone, may help patients self-monitor their blood pressure at home, allowing for intelligent management of hypertension. The aim of this trial is to investigate whether IHMS can effectively reduce blood pressure in patients with hypertension.
This is a multiple-centre, prospective, randomised, controlled study. 320 eligible subjects will be randomly divided into the IHMS management group (n=160) and the conventional care group (n=160). Subjects in the IHMS management group will be required to take their blood pressure daily at regular intervals at home and get treatment as directed by the IHMS; the control group will receive conventional treatment. The primary outcome of the trial is the net change in systolic blood pressure at the end point of follow-up after 3 months. The mixed-effects model will be used to compare the primary outcome that there is a greater reduction in blood pressure in the intervention group than in the control group.
The Ethics Committee of Shanghai Tongren Hospital has reviewed and approved the trial protocols, informed consent and subject information. The findings from the study will be disseminated through publications and conference presentations. The findings of the trial will be published in journals and presented at academic conferences.
This study aimed to estimate the pooled level of self-care behaviour among heart failure patients in Ethiopia.
Systematic review and meta-analysis.
PubMed/MEDLINE, HINARI, Web of Sciences, Scopus, Google Scholar, Science Direct, African journals online and University repositories were searched from 1 January 2000 to 1 November 2023.
We include studies that examined self-care behaviour among heart failure patients, studies that report factors associated with self-care behaviour and observational studies (cross-sectional, case-control and cohort) with full text available.
The data were extracted with Microsoft Excel and analysed by using STATA V.11 software. The weighted inverse variance random-effects model at 95% CI was used to estimate the pooled level of self-care behaviour and its associated factors among heart failure patients. Tests of heterogeneity, test of publication bias and subgroup analyses were also employed.
Thirteen cross-sectional studies with 4321 study participants were included; and the pooled level of good self-care behaviour among heart failure patients in Ethiopia was found to be 38.3% (95% CI 31.46 to 45.13). Only 68.8% of heart failure patients were knowledgeable about heart failure. Knowledge about heart failure (Adjusted Odds Ratio (AOR)=3.39; 95% CI 2.42 to 4.74) and absence of comorbidity (AOR=2.69; 95% CI 1.35 to 5.37) were significantly associated with good self-care behaviour among heart failure patients in Ethiopia.
The majority of heart failure patients in Ethiopia did not adhere to the recommended self-care behaviours. Nearly one-third of heart failure patients were not knowledgeable about heart failure. Knowledge about heart failure and the absence of comorbidities were significantly associated with good self-care behaviour. Therefore, efforts should be devoted to increasing knowledge and preventing comorbidities among heart failure patients.
CRD42023394373.
Percutaneous coronary intervention (PCI) guided by coronary angiography-derived fractional flow reserve (FFR) or intravascular ultrasound (IVUS) has shown improved clinical outcomes compared with angiography-only-guided PCI. In patients with intermediate stenoses, FFR resulted in fewer coronary interventions and was non-inferior to IVUS with respect to clinical outcomes. However, whether this finding can be applied to angiography-derived FFR in significant coronary artery disease (CAD) remains unclear.
The comparison of angiography-derived FFR-guided and IVUS-guided intervention strategies for clinical outcomes in patients with coronary artery disease (FLAVOUR II) trial is a multicentre, prospective, randomised controlled trial. A total of 1872 patients with angiographically significant CAD (stenoses of at least 50% as estimated visually through angiography) in a major epicardial coronary artery will be randomised 1:1 to receive either angiography-derived FFR-guided or IVUS-guided PCI. Patients will be treated with second-generation drug-eluting stent according to the predefined criteria for revascularisation: angiography-derived FFR≤0.8 and minimal lumen area (MLA)≤3 mm2 or 3 mm2
The FLAVOUR II trial will provide new insights into optimal evaluation and treatment strategies for patients with CAD.
FLAVOUR II was approved by the institutional review board at each participating site (The Second Affiliated Hospital of Zhejiang University School of Medicine Approval No: 2020LSYD410) and will be conducted in line with the Declaration of Helsinki. Informed consent would be obtained from each patient before their participation. The study results will be submitted to a scientific journal.
Atrial fibrillation (AF) is a major public health issue and there is rationale for the early diagnosis of AF before the first complication occurs. Previous AF screening research is limited by low yields of new cases and strokes prevented in the screened populations. For AF screening to be clinically and cost-effective, the efficiency of identification of newly diagnosed AF needs to be improved and the intervention offered may have to extend beyond oral anticoagulation for stroke prophylaxis. Previous prediction models for incident AF have been limited by their data sources and methodologies.
We will investigate the application of random forest and multivariable logistic regression to predict incident AF within a 6-month prediction horizon, that is, a time-window consistent with conducting investigation for AF. The Clinical Practice Research Datalink (CPRD)-GOLD dataset will be used for derivation, and the Clalit Health Services (CHS) dataset will be used for international external geographical validation. Analyses will include metrics of prediction performance and clinical utility. We will create Kaplan-Meier plots for individuals identified as higher and lower predicted risk of AF and derive the cumulative incidence rate for non-AF cardio-renal-metabolic diseases and death over the longer term to establish how predicted AF risk is associated with a range of new non-AF disease states.
Permission for CPRD-GOLD was obtained from CPRD (ref no: 19_076). The CPRD ethical approval committee approved the study. CHS Helsinki committee approval 21-0169 and data usage committee approval 901. The results will be submitted as a research paper for publication to a peer-reviewed journal and presented at peer-reviewed conferences.
A systematic review to guide the overall project was registered on PROSPERO (registration number CRD42021245093). The study was registered on ClinicalTrials.gov (NCT05837364).
This study aimed to assess the International Quality Improvement Collaborative single-site data from a developing country to identify trends in outcomes and factors associated with poor outcomes.
Retrospective descriptive study.
The National Institute of Cardiovascular Diseases, Karachi, Pakistan.
Patients undergoing surgery for congenital heart disease (CHD).
Key factors were examined, including preoperative, procedural and demographic data, as well as surgical complications and outcomes. We identified risk factors for mortality, bacterial sepsis and 30-day mortality using multivariable logistic regression.
A total of 3367 CHD surgical cases were evaluated; of these, 59.4% (2001) were male and 82.8% (2787) were between the ages of 1 and 17 years. Only 0.2% (n=6) were infants (≤30 days) and 2.3% (n=77) were adults (≥18 years). The in-hospital mortality rate was 6.7% (n=224), and 4.4% (n=147) and 0.8% (n=27) had bacterial sepsis and surgical site infections, respectively. The 30-day status was known for 90.8% (n=3058) of the patients, of whom 91.6% (n=2800) were alive. On multivariable analysis, the adjusted OR for in-hospital mortality was 0.40 (0.29–0.56) for teenagers compared with infancy/childhood and 1.95 (1.45–2.61) for patients with oxygen saturation
We observed a high prevalence of postoperative infections and mortality, especially for high-risk procedures, according to RACHS-1 risk category, in infancy/childhood, in children with genetic syndrome or those with low oxygen saturation (
The aim of this study was to understand how patients experienced hypertension management, with or without blood pressure (BP) telemonitoring, during the COVID-19 pandemic.
This qualitative study conducted between April and November 2022 consisted of 43 semistructured telephone interviews (23 men and 20 women) from 6 primary care practices in one area of Scotland.
From the views of 25 participants with experience of using the Connect Me telemonitoring service and 18 participants without such experience, 5 themes were developed. These were: (1) navigating access to services. There were challenges to gaining timely and/or in-person access to services and a reluctance to attend clinical settings because participants were aware of their increased risk of contracting the COVID-19 virus. (2) Adapting National Health Service services. All six practices had adapted care provision in response to potential COVID-19 transmission; however, these adaptations disrupted routine management of in-person primary care hypertension, diabetes and/or asthma checks. (3) Telemonitoring feedback. Telemonitoring reduced the need to attend in-person primary care practices and supported access to remote healthcare monitoring and feedback. (4) Self-management. Many non-telemonitoring participants were motivated to use self-management strategies to track their BP using home monitoring equipment. Also, participants were empowered to self-manage lifestyle and hypertension medication. (5) Experience of having COVID-19. Some participants contracting the COVID-19 virus experienced an immediate increase in their BP while a few experienced ongoing increased BP readings.
The COVID-19 pandemic disrupted routine in-person care for patients with hypertension. Both telemonitoring and some non-telemonitoring patients were motivated to self-manage hypertension, including self-adjusting medication; however, only those with access to telemonitoring had increased access to hypertension monitoring and feedback. BP telemonitoring permitted routine care to continue for participants in this study and may offer a service useful in pandemic proofing hypertension healthcare in the future.
Whether the glucose-insulin-potassium (GIK) should be used as an adjuvant therapy for ischaemic myocardial disease remains controversial nowadays reperfusion era. This meta-analysis aimed to assess the effects of preinitiated GIK for patients undergoing planned percutaneous coronary intervention (PCI).
Systematic review and meta-analysis.
PubMed, Web of science, MEDLINE, Embase, Cochrane Library and ClinicalTrials.gov were searched through 27 November 2022.
Only randomised controlled trials involving participants preinitiated with GIK or placebo before planned PCI were included.
Two independent reviewers used standardised methods to search, screen and code included trials. Risk of bias was assessed with the Cochrane tool. Pooled analysis was conducted using random or effects models according to the heterogeneity. Subgroup analyses were carried out for dosage of GIK and if with ongoing myocardial ischaemia.
13 randomised controlled trials (RCTs) including 3754 participants were evaluated. We found patients preconditioned with GIK before PCI showed a significant increase in Thrombolysis in Myocardial Infarction 3 flow events after angioplasty (OR 1.59, 95% CI 1.03 to 2.46, p=0.04), also revealed improved in-hospital left ventricular ejection fraction (weighed mean difference, WMD 1.62, 95% CI 0.21 to 3.03, p=0.02) and myocardial salvage index (WMD 0.09, 95% CI 0.01 to 0.16, p=0.03). Nevertheless, no benefit was observed in all-cause mortality neither on 30-day (OR 0.81, 95% CI 0.59 to 1.11, p=0.18) nor 6 months (OR 1.02, 95% CI 0.42 to 2.46, p=0.97). Furthermore, GIK intervention was associated with higher occurrences of complications such as phlebitis (OR 10.13, 95% CI 1.74 to 59.00, p=0.01) and hypoglycaemia (OR 10.43, 95% CI 1.32 to 82.29, p=0.03), but not hyperkalaemia (OR 9.36, 95% CI 0.50 to 175.27, p=0.13), liquid overload (OR 1.02, 95% CI 0.25 to 4.13, p=0.98) or in-hospital heart failure (OR 0.42, 95% CI 0.06 to 2.96, p=0.39).
Our study shows preconditioning GIK exhibits myocardial reperfusion and cardiac function benefits for patients planning to receive PCI intervention, while also some complications such as phlebitis and hypoglycaemia accompany.
CRD42022326334.
Clinic-based or community-based interventions can improve adherence to guideline-directed medication therapies (GDMTs) among patients with heart failure (HF). However, opportunities for such interventions are frequently missed, as providers may be unable to recognise risk patterns for medication non-adherence. Machine learning algorithms can help in identifying patients with high likelihood of non-adherence. While a number of multilevel factors influence adherence, prior models predicting non-adherence have been limited by data availability. We have established an electronic health record (EHR)-based cohort with comprehensive data elements from multiple sources to improve on existing models. We linked EHR data with pharmacy refill data for real-time incorporation of prescription fills and with social determinants data to incorporate neighbourhood factors.
Patients seen at a large health system in New York City (NYC), who were >18 years old with diagnosis of HF or reduced ejection fraction (
Among 39 963 patients in the cohort, the average age was 73±14 years old, 44% were female and 48% were current/former smokers. The common comorbid conditions were hypertension (77%), cardiac arrhythmias (56%), obesity (33%) and valvular disease (33%). During the study period, 33 606 (84%) patients had an active prescription of beta blocker, 32 626 (82%) had ACEi/ARB/ARNI, 11 611 (29%) MRA and 7472 (19%) SGLT2i. Ninety-nine per cent were from urban metropolitan areas.
We will use the established cohort to develop a machine learning model to predict medication adherence, and to support ancillary studies assessing associates of adherence. For external validation, we will include data from an additional hospital system in NYC.
Dietary sodium intake represents a risk factor for cardiovascular disease and mortality. The study sought to analyse the sodium content of effervescent dietary supplements and drugs in Germany and the USA.
Comparative cross-sectional study.
The sodium content of 39 dietary supplement effervescent tablets available in Germany was measured in May and June 2022 using optical emission spectrometry with inductively coupled argon plasma. The sodium content of 33 common pharmacy-only effervescent tablets (over-the-counter (OTC) drugs) in Germany was obtained from the summary of product characteristics. We compared the sodium content of the measured German dietary supplement effervescent tablets to that of 51 dietary supplement effervescent tablets available in the USA (data: National Institutes of Health’s Dietary Supplement Label Database).
The measured sodium content in the German dietary supplements was 283.9±122.6 mg sodium/tablet, equivalent to 14±6% of the maximum recommended daily sodium intake (MRDSI). Vitamin products had the highest (378.3±112.8 mg, 19±6% of MRDSI), and calcium products had the lowest mean sodium content (170.4±113.2 mg, 9±6% of MRDSI). Vitamin products contained significantly more sodium than magnesium (378.3 mg vs 232.7 mg; p=0.004), calcium (378.3 mg vs 170.4 mg; p=0.006) and mineral products (378.3 mg vs 191.6 mg; p=0.048). The sodium content measured in products available in Germany was higher when compared with the declared sodium content on the label of the products sold in the USA (283.9 mg vs 190.0 mg; p
Effervescent tablets of nutritional supplements and OTC drugs contain high amounts of sodium, which often is not disclosed.
Evidence linking dietary potassium and serum potassium is virtually scarce and inconclusive. The aim of the study was to investigate the association between serum potassium level and potassium intake measured by 24-hour urine. We also explored whether the association differed across health conditions.
A cross-sectional study conducted from September 2017 to March 2018.
48 residential elderly care facilities in northern China.
Participants aged 55 years and older and with both serum potassium and 24-hour urinary potassium measured were classified as having a low (apparently healthy), moderate (with ≥1 health condition but normal renal function) and high (with ≥1 health condition and abnormal renal function) risk of hyperkalaemia.
Potassium intake is measured by 24-hour urinary potassium.
Serum potassium in association with potassium intake after adjustment for age, sex, region and accounting for the cluster effect.
Of 962 eligible participants (mean age 69.1 years, 86.8% men), 17.3% were at low risk, 48.4% at moderate risk and 34.3% at high risk of hyperkalaemia. Serum potassium was weakly associated with 24-hour urinary potassium among individuals with moderate (adjusted β=0.0040/L; p=0.017) and high (adjusted β=0.0078/L; p=0.003) but not low (adjusted β=0.0018/L; p=0.311) risk of hyperkalaemia.
A weak association between dietary potassium intake and serum potassium level existed only among individuals with impaired renal function or other health conditions but not among apparently healthy individuals. The results imply that increasing dietary potassium intake may slightly increase the risk of hyperkalaemia but may also decrease the risk of hypokalaemia in unhealthy individuals, both of which have important health concerns.
NCT03290716; Post-results.
Atrial fibrillation (AF) is a major risk factor for ischaemic stroke and transient ischaemic attack (TIA), and AF detection can be challenged by asymptomatic and paroxysmal presentation. Long-term ECG monitoring after ischaemic stroke or TIA is recommended by all major societies in cardiology and cerebrovascular medicine as a secondary prophylactic measure. However, data on stroke reduction are lacking, and the recommendations show significant diversity.
AF SPICE is a multicentre, national, investigator-initiated, randomised, parallel-group, register-based trial comparing extended ECG monitoring versus standard ECG monitoring in patients admitted with ischaemic stroke or TIA, with a composite endpoint of stroke, all-cause-mortality and intracerebral bleeding. Patients aged ≥70 years without previous AF will be randomised 1:1 to control (standard ECG monitoring) or intervention (extended ECG monitoring). In the control arm, patients will undergo 48±24 hours (ie, a range of 24–72 hours) of continuous ECG monitoring according to national recommendations. In the intervention arm, patients will undergo 14+14 days of continuous ECG monitoring 3 months apart using an ECG patch device, which will provide an easy-accessed, well-tolerated 14-day continuous ECG recording. All ECG patch recordings will be read in a core facility. In cases of AF detection, oral anticoagulation will be recommended if not contraindicated. A pilot phase has been concluded in 2022, which will transcend into the main trial during 2023–2026, including approximately 30 stroke units. The sample size was calculated to be 3262 patients. The primary outcome will be collected from register data during a 36-month follow-up.
Ethical approval has been provided by the Swedish Ethical Review Authority, reference 2021–02770. The trial will be conducted according to the ethical principles of the Declaration of Helsinki and national regulatory standards. Positive results from the study have the potential for rapid dissemination in clinical practice.
The implementation of a heart team still faces many challenges which may be facilitated with advanced communication technology. There is a knowledge gap to support the use of an electronic real-time heart team decision-making approach based on communication technology in the real clinical practice and evaluate its safety and feasibility in patients with complex coronary artery disease (CAD).
The EHEART (Electronic HEArt team with Real-Time decision-making) trial is a prospective, multicentre, two-arm, randomised controlled trial that will randomise 490 patients with complex CAD to either an electronic real-time heart team group or conventional heart team group. For patients allocated to the real-time electronic group, heart team meetings will be initiated during the coronary angiography and guided by a supporting system based on communication technology to help with information synchronisation, real-time communication between specialists, meeting process recording and assistance and joint decision-making with patients’ families. The primary and safety endpoint is a composite of all-cause death, myocardial infarction, stroke, revascularisation or re-angina hospital admission at 1 year. The primary secondary outcome is the time interval from the coronary angiography to the final treatment, which is the major indicator of feasibility. We will also compare the practical feasibility from the specialist’s and patient’s perspectives (for example, specialist’s workload and patient’s decision results) between the two groups.
The study was approved by the Institutional Review Board (IRB) of Fuwai Hospital (no. 2022-1749). Informed consent will be obtained from all participants. The results of this trial will be disseminated through manuscript publication and national/international conferences, and reported in the trial registry entry.
ClinicalTrials.gov Registry (NCT05514210).
The strategy for initiating antithrombotic therapy to prevent bioprosthetic valve thrombosis (BPVT) after transcatheter aortic valve replacement (TAVR) remains uncertain. There is still lacking evidence on the efficacy and safety of early 6 months usage of single-antiplatelet therapy (SAPT) or oral anticoagulant (OAC) after TAVR in patients without anticoagulant indications.
This is a multicentre, randomised controlled, open-label trial, and 650 patients undergoing TAVR from 13 top TAVR centres in China will be recruited. Each eligible participant will be randomly assigned to two groups (1:1 ratio) as (1) SAPT (aspirin 75–100 mg for 6 months) group or (2) OAC group (warfarin, therapeutic international normalised ratio at 1.8–2.5 for 6 months), both followed by sequential aspirin 75–100 mg for 6 months. Participants in both groups will be invited for three follow-up visits of 1, 6 and 12 months after discharge. We will use both the net clinical benefit endpoint (composite of all-cause mortality, myocardial infarction, stroke/transient ischaemic attacks, peripheral artery thrombosis, intracardiac thrombosis and major bleeding and disabling or life-threatening bleeding) and the BPVT endpoint evaluated by four-dimensional CT as our primary endpoints. P value of
The present study was approved by the Institutional Review Boards at Fuwai Hospital, National Center for Cardiovascular Diseases of China (Approval No. 2023-1947). All patients will be informed of the details of the study and will sign an informed consent prior to inclusion in the study. Results of this study will be published in a peer-reviewed journal.
To investigate the association of fat and lean mass in specific regions with all-cause and cardiovascular-related mortality.
Population based cohort study.
US National Health and Nutrition Examination Survey (2003–2006 and 2011–2018).
22 652 US adults aged 20 years or older.
Fat and lean mass in specific regions obtained from the whole-body dual-energy X-ray absorptiometry.
All-cause and cardiovascular-related mortality.
During a median of 83 months of follow-up, 1432 deaths were identified. Associations between body composition metrics and mortality risks were evident above specific thresholds. For all-cause mortality, Android fat mass showed elevated HRs above 2.46 kg (HR: 1.17, 95% CI 1.02 to 1.34), while Android lean mass (ALM) had similar trends above 2.75 kg (HR: 1.17, 95% CI 1.03 to 1.33), and Android total mass above 5.75 kg (HR: 1.08, 95% CI 1.01 to 1.16). Conversely, lower HRs were observed below certain thresholds: Gynoid fat mass (GFM) below 3.71 kg (HR: 0.72, 95% CI 0.56 to 0.93), Gynoid lean mass below 6.44 kg (HR: 0.77, 95% CI 0.64 to 0.92), and Gynoid total mass below 11.78 kg (HR: 0.76, 95% CI 0.70 to 0.84). Notably, below 0.722 kg, the HR of visceral adipose tissue mass (VATM) was 1.25 (95% CI 1.04 to 1.48) for all-cause mortality, and above 3.18 kg, the HR of total abdominal fat mass was 2.41 (95% CI 1.15 to 5.05). Cardiovascular-related mortality exhibited associations as well, particularly for Android fat mass (AFM) above 1.78 kg (HR: 1.22, 95% CI 1.01 to 1.47) and below 7.16 kg (HR: 0.50, 95% CI 0.36 to 0.69). HRs varied for Gynoid total mass below and above 10.98 kg (HRs: 0.70, 95% CI 0.54 to 0.93, and 1.12, 95% CI 1.02 to 1.23). Android per cent fat, subcutaneous fat mass (SFM), AFM/GFM, and VATM/SFM were not statistically associated with all-cause mortality. Android per cent fat, Gynoid per cent fat, AFM/GFM, and VATM/SFM were not statistically associated with cardiovascular-related mortality. Conicity index showed that the ALM/GLM had the highest performance for all-cause and cardiovascular-related mortality with AUCs of 0.785, and 0.746, respectively.
The relationship between fat or lean mass and all-cause mortality varies by region. Fat mass was positively correlated with cardiovascular mortality, regardless of the region in which they located. ALM/GLM might be a better predictor of all-cause and cardiovascular-related mortality than other body components or body mass index.
FreshRSS 