SecondarY Prevention and MaNagement of Myocardial Injury AftER Noncardiac SurGerY (SYNERGY) Pilot Trial

NCT ID: NCT06768034

Last Updated: 2025-01-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-31
• Study Completion Date: 2026-03-31

Brief 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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Standard of care

Patients who had myocardial injury after noncardiac surgery are assigned to receive usual care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Systematic referral for secondary cardiovascular prevention

Systematic referral to an internist within 6 weeks after myocardial injury after noncardiac surgery for implementation of secondary cardiovascular prevention strategies, individualized the patient's risk factors.

Group Type: ACTIVE_COMPARATOR

Intervention Group

Intervention Type: PROCEDURE

Patients being referred to an internist or cardiologist after myocardial injury after noncardiac surgery

Interventions

Intervention Group

Patients being referred to an internist or cardiologist after myocardial injury after noncardiac surgery

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Have undergone noncardiac surgery,

2. Had a myocardial injury after noncardiac surgery with a presumed ischemic mechanism and without an overt nonischemic precipitating etiology (e.g., sepsis)

3. Provide written informed consent to participate in the SYNERGY pilot trial.

Exclusion Criteria

1. already on 2 of 3 secondary cardiovascular prevention medications (i.e., antiplatelet, statin, and/or angiotensin-converting enzyme inhibitor (ACEI)/angiotensin II receptor blocker (ARB)

2. patients with contraindication to statins (i.e., decompensated or Child-Pugh C cirrhosis, acute liver failure, elevated AST/ALT greater than 2-fold the normal upper limit, previous demonstrated statin hypersensitivity, allergy, or statin-related myopathy);

3. patients with contraindication to antiplatelet therapy (i.e., active or recent <1-month peptic ulcer disease, esophageal or gastric variceal disease, history of intracranial or intraspinal hemorrhage, significant thrombocytopenia with platelet count <50 × 109/L),

4. patients with contraindication to ACEI and ARB therapy (i.e, hypersensitivity or allergy to ACEI or ARB);

5. Previously enrolled in the SYNERGY pilot trial,

6. Considered unreliable or unable to complete the trial procedures.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role: lead

Responsible Party

Emmanuelle Duceppe MD PhD

Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emmanuelle Duceppe, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Centre hospitalier de l'Université de Montréal (CHUM)

Locations

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

Countries

Canada

Central Contacts

Melodie Boko, MSc

Role: CONTACT

synergy.dri.chum@ssss.gouv.qc.ca

514-890-8000 ext. 31541

Facility Contacts

Emmanuelle Duceppe, MD PhD

Role: primary

emmanuelle.duceppe.med@ssss.gouv.qc.ca

514-890-8000

Other Identifiers

2024-12117

Identifier Type: -

Identifier Source: org_study_id