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

NCT06768034 | Not Yet Recruiting

• 1 other identifier: 2024-12117
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Injury After Noncardiac Surgery (MINS)

Keywords

Noncardiac surgery; Secondary cardiovascular prevention; Randomized controlled trial

Outcome Measures

Primary Outcomes (3)

• Average recruitment rate

  Average number of patients recruited per month. Feasibility is defined as average recruitment rate ≥3 patients/month/site as "trial feasible", between 1-2 patients/month/site as "potentially feasible with protocol modifications", and \<1 patient/month/site as "unlikely feasible".

  12 months

• Proportion adherence to referral to specialized cardiovascular care in the intervention group

  Defined as the proportion of patients allocated to the intervention group with referral to internal medicine or cardiology within 6 weeks of MINS. The adherence feasibility outcome is defined as follows: ≥70% as "trial feasible", between 40-69% "potentially feasible with protocol modifications", and \<40% "unlikely feasible".

  6 months

• Proportion crossover to referral to specialized CV care in the control group

  Defined as the proportion of patients allocated to the control group with referral to internal medicine or cardiology within 6 weeks of MINS. The crossover feasibility outcome is defined as follows: \<30% as "trial feasible", between 30-49% "potentially feasible with protocol modifications", and \>50% "unlikely feasible".

  6 months

Secondary Outcomes (23)

• Proportion of prescription of cardiovascular medications

  6 months

• Proportion of patients on antiplatelet therapy

  6 months

• Proportion of patients on statin therapy

  6 months

• Proportion of patients on angiotensin-converting enzyme inhibitor (ACEI)/angiotensin II receptor blocker (ARB)

  6 months

• Proportion consent of eligible patients

  12 months

Study Arms (2)

Standard of care

NO INTERVENTION

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

Systematic referral for secondary cardiovascular prevention

ACTIVE COMPARATOR

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.

Procedure: Intervention Group

Interventions

Intervention Group PROCEDURE

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

Systematic referral for secondary cardiovascular prevention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Have undergone noncardiac surgery,
• Had a myocardial injury after noncardiac surgery with a presumed ischemic mechanism and without an overt nonischemic precipitating etiology (e.g., sepsis)
• Provide written informed consent to participate in the SYNERGY pilot trial.

You may not qualify if:

• 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)
• 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);
• 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),
• patients with contraindication to ACEI and ARB therapy (i.e, hypersensitivity or allergy to ACEI or ARB);
• Previously enrolled in the SYNERGY pilot trial,
• Considered unreliable or unable to complete the trial procedures.

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• Heart and Stroke Foundation of Canada: collaborator

Study Sites (1)

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 0C1, Canada

Location

Study Officials

• Emmanuelle Duceppe, MD PhD

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melodie Boko, MSc

CONTACT

514-890-8000; synergy.dri.chum@ssss.gouv.qc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: January 10, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)