Inflammation plays a central role in atherosclerosis development and subsequent cardiovascular complications, including heart attack and stroke. Patients with inflammatory conditions such as community-acquired pneumonia (CAP) present with an elevated risk of cardiovascular events, which is likely driven by unresolved systemic inflammation. Targeting this heightened inflammatory burden may present a novel therapeutic strategy to attenuate heart attack risk in CAP survivors. Icosapent ethyl (IPE), an omega-3 fatty acid, demonstrates both pro-resolving and cardioprotective properties. The Targeting Vascular Inflammation In Patients with CAP (TIN-CAP) trial aims to evaluate the efficacy of IPE in mitigating vascular inflammation in CAP survivors.

TIN-CAP is a multicentre, randomised, double-blind, placebo-controlled trial. Eligible adults diagnosed with CAP in hospital or the emergency department will complete baseline assessments within 14 days of diagnosis including ¹⁸F-fluorodeoxyglucose (FDG) positron emission tomography/CT angiography, bloodwork and quality of life evaluation (EuroQol – 5 Dimensions (EQ-5D)). Participants will then be randomised 1:1 to receive IPE (4 g/day) or placebo for 6 months. Follow-up visits will occur at 30 days (bloodwork and EQ-5D only) and 6 months. The primary endpoint is the change in FDG uptake in the ascending aorta from baseline to 6 months between IPE and placebo groups. Secondary endpoints include FDG uptake in the bone marrow, spleen, lungs and other vasculature, in addition to major adverse cardiac events and quality of life assessments. An initial lead-in cohort of 18 patients will be enrolled to assess recruitment, imaging feasibility and IPE tolerability prior to full trial enrolment. These patients will remain blinded and will be included in the final analysis (Vanguard design).

The TIN-CAP trial has been approved provincially by the Clinical Trials Ontario Research Ethics Board (approval number: 5045). Participants will provide written informed consent prior to enrolment. Study findings will be disseminated through peer-reviewed publications and conference presentations.

NCT06710080.

Nicotine vaping is common among children and youth, and even more so among those with mental health concerns. Identifying and managing nicotine vaping in child and youth mental health treatment settings is key to addressing this modifiable risk factor for poorer physical and mental health in young people. Recommendations exist for screening, assessment and treatment of youth vaping; however, it remains unclear whether current practices in child and youth mental health programmes align with recommended standards.

An explanatory sequential mixed methods design with three stages will be employed. In the first stage, a cross-sectional survey will be distributed to all eligible Canadian hospitals to identify practices in assessment and treatment of nicotine vaping within their child and youth mental health and addictions programmes. This survey will also assess barriers and facilitators for the uptake of the 2021 Canadian Paediatric Society recommendations on management of youth vaping. Semi-structured focus groups and interviews will be conducted in stage two, with clinicians, managers, youth and caregivers. Qualitative data will be analysed using a reflexive thematic approach. In stage three, findings and proposed behaviour change interventions will be reviewed at a knowledge mobilisation meeting with the goal of developing a national knowledge mobilisation plan to improve assessment and treatment of youth vaping in hospital-based mental health and addictions programmes.

This study has received ethics approval from the Research Ethics Board at the Children’s Hospital of Eastern Ontario (Protocol #25/19X). Participants will provide informed consent prior to participating. Results will be published in peer-reviewed journals and presented at scientific conferences. Summaries will be provided to the funders of the study and to participating hospitals.