NCT06768034

SecondarY Prevention and maNagement of Myocardial Injury aftER Noncardiac surGerY (SYNERGY) Pilot Trial

A Pilot Pragmatic Randomized Controlled Trial Evaluating Secondary Cardiovascular Prevention Therapies in Patients Who Had a Myocardial Injury After Noncardiac Surgery to Prevent Major Cardiovascular Events

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Cardiac complications, particularly myocardial injury after noncardiac surgery (MINS), significantly contribute to 30-day mortality, affecting about 1 in 10 patients after noncardiac surgery. Despite its prevalence and serious implications, there is no consensus on managing myocardial injury after noncardiac surgery in clinical practice. Interventions commonly used for cardiovascular prevention in patients who had a heart attack outside of a surgery context could also be beneficial in patient with MINS. This pilot study trial aims to gather feasibility data, such as recruitment rates and intervention adherence that will guide on the design and inform on sample size of a future study with large pragmatic randomized controlled trial on the impact of systematic referral for secondary cardiovascular prevention on outcomes in patients who had a MINS.

Detailed description

The SYNERGY study is a pilot randomized controlled trial with 100 patients who had myocardial injury after noncardiac surgery (MINS). Patients are assigned to either a control group receiving usual care or an intervention group that receives referral to a specialist for implementations of interventions on secondary cardiovascular prevention. Secondary cardiovascular prevention will be individualized to the patient's risk factors and may include antiplatelet agents, cholesterol-lowering treatment, blood pressure-lowering medication, as well as counselling on healthy lifestyle choices on diet and exercise, including, if applicable, optimization of diabetes treatment and help in quitting smoking. At six months, follow-up will assess clinical cardiovascular outcomes, medication adherence, smoking status, adherence to a Mediterranean diet and physical activity. Key feasibility metrics include recruitment rate, intervention adherence, crossover in the control group, and changes physical activity and dietary pattern. This study aims to address untreated myocardial injury after noncardiac surgery by collecting feasibility data to inform on the design of a future large randomized clinical trials on secondary cardiovascular prevention.

Conditions

• Myocardial Injury After Noncardiac Surgery (MINS)

Interventions

Type	Name	Description
PROCEDURE	Intervention Group	Patients being referred to an internist or cardiologist after myocardial injury after noncardiac surgery

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-05-01
• Completion: 2027-11-01
• First posted: 2025-01-10
• Last updated: 2026-03-19

Locations

1 site across 1 country: Canada