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Myocardial Injury After Noncardiac Surgery (MINS)NCT06768034

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

A study testing Intervention Group in people with Myocardial Injury After Noncardiac Surgery (MINS), run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record

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Trial 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. Read more about this study

Who is it for?
Any age
What is being tested?
Intervention Group
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteCanada
Study dates
Apr 2026to Nov 2027
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Canada1 site
  • Centre Hospitalier de l'Université de Montréal

    Montreal, Quebec, H2X 0C1

    Emmanuelle Duceppe, MD PhD, 514-890-8000, emmanuelle.duceppe.med@ssss.gouv.qc.ca

Other trials in Canada

About this study

Official title: 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

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.

Read the 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.

Being tested
Intervention Group
Keywords
Noncardiac surgery, Secondary cardiovascular prevention, Randomized controlled trial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intervention GroupProcedure or surgery

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

Study groups in NCT06768034
Study groupRoleWhat they receive
Standard of careNo interventionPatients who had myocardial injury after noncardiac surgery are assigned to receive usual care.
Systematic referral for secondary cardiovascular preventionActive comparatorSystematic 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.
Receives: Procedure: Intervention Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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".

    Measured: 12 months

  2. 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".

    Measured: 6 months

  3. 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".

    Measured: 6 months

Secondary outcomes (23)
  1. Proportion of prescription of cardiovascular medications

    Proportion of patients who are prescribed an antiplatelet, statin, and angiotensin-converting enzyme inhibitor (ACEI)/angiotensin II receptor blockers (ARB) (all three) at 6 months.

    Measured: 6 months

  2. Proportion of patients on antiplatelet therapy

    Proportion of patients who are prescribed an antiplatelet therapy.

    Measured: 6 months

  3. Proportion of patients on statin therapy

    Proportion of patients who are prescribed a statin.

    Measured: 6 months

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

    Proportion of patients who are prescribed an angiotensin-converting enzyme inhibitor (ACEI)/angiotensin II receptor blocker (ARB).

    Measured: 6 months

  5. Proportion consent of eligible patients

    Proportion of eligible patients which consented to participate in the trial

    Measured: 12 months

  6. Proportion of completeness to follow-up

    Proportion of patients enrolled in the trial that completed the 6-month follow-up

    Measured: 6 months

  7. Change in IPAQ score

    Difference in physical activity score (i.e., the short form of the International Physical Activity Questionnaire (IPAQ-SF) score in metabolic equivalents (METs) minute per week) between baseline and 6 months, expressed as a continuous outcome, with higher values meaning a larger increase in physical activity level.

    Measured: 6 months

  8. Change in MEDAS score

    Difference between the Mediterranean Diet Adherence Screener (MEDAS) questionnaire score at baseline and 6 months (score between 0 and 14, with high score reflecting higher adherence).

    Measured: 6 months

  9. Proportion of major cardiovascular events

    Proportion of patients who experience any of the following composite of cardiovascular death, non-fatal cardiac arrest, myocardial infarction, stroke, heart failure, and coronary revascularization.

    Measured: 6 months

  10. Proportion of cardiovascular death

    Proportion of patients with a cardiovascular death is defined as any death with a cardiovascular cause and includes those deaths following a myocardial infarction, sudden cardiac arrest, stroke, cardiac revascularization procedure (i.e., percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery), and heart failure.

    Measured: 6 months

  11. Proportion of myocardial infarction

    Proportion of patients with a myocardial infarction as defined according to the Fourth Universal Definition of Myocardial Infarction.

    Measured: 6 months

  12. Proportion of non-fatal cardiac arrest

    Proportion of patients with a nonfatal cardiac arrest defined as successful resuscitation from either documented or presumed ventricular fibrillation, sustained ventricular tachycardia, asystole, or pulseless electrical activity requiring cardiopulmonary resuscitation, pharmacological therapy, or cardiac defibrillation.

    Measured: 6 months

  13. Proportion of coronary revascularization

    Proportion of patients with a cardiac revascularization procedures including percutaneous coronary intervention (PCI) and coronary arterial bypass grafting (CABG).

    Measured: 6 months

  14. Proportion of stroke

    Proportion of patients with a stroke defined as either:

    1. a new focal neurological deficit thought to be vascular in origin with signs or symptoms lasting more than 24 hours or leading to death, OR
    2. a new focal neurological deficit thought to be vascular in origin with signs or symptoms lasting less 24 hours with a positive neuroimaging consistent with a stroke.

    Measured: 6 months

  15. Proportion of transient ischemic attack

    Proportion of patients with a transient ischemic attack defined as rapidly developed and transient clinical signs of focal or global disturbance of cerebral function, lasting less than 24 hours, with either 1) direct weighted magnetic resonance findings of acute brain ischemic lesions, or 2) high risk neurologic features (i.e., lateralizing weakness and/or speech disruption lasting >5 min).

    Measured: 6 months

  16. Proportion of heart failure

    Proportion of patients with a diagnosis of heart fialure, as defined by (criteria A and B required):

    1. New or worsening symptoms due to heart failure (HF), including at least ONE of the following:
    2. Shortness of breath (dyspnea with exertion, dyspnea at rest, orthopnea, paroxysmal nocturnal dyspnea), 2. Decreased exercise tolerance, or 3. Fatigue.
    3. Signs of new or worsening HF, consisting of at least TWO physical examination findings OR one physical examination finding and at least ONE laboratory (i.e., natriuretic peptide elevation) or radiological imaging.

    Measured: 6 months

  17. Proportion of all-cause mortality

    Proportion of patients who died of any cause.

    Measured: 6 months

  18. Proportion of new significant arrythmia

    Proportion of patients with a new significant arrythmia defined as new supraventricular or ventricular arrythmia that results in angina, congestive heart failure, symptomatic hypotension, or that requires oral or intravenous treatment with a rate controlling drug, antiarrhythmic drug, electrical cardioversion, implantation of a pacemaker or implantable cardioverter defibrillator.

    Measured: 6 months

  19. Proportion of major bleeding

    Proportion of patients with a major bleeding defined according to the criteria of International Society on Thrombosis and Haemostasis (ISTH) as clinically overt bleeding which was fatal or associated with any of the following:

    1. a fall in hemoglobin level of 2 g/dL or more or documented transfusion of at least 2 units of packed red blood cells,
    2. involvement of a critical anatomical site (intracranial, spinal, ocular, pericardial, articular, intramuscular with compartment syndrome, retroperitoneal).

    Measured: 6 months

  20. Proportion of clinically relevant non-major bleeding

    Proportion of patients with a clinically relevant non-major bleeding defined as any sign or symptom of hemorrhage (e.g., more bleeding than would be expected for a clinical circumstance, including bleeding found by imaging alone) that does not fit the criteria for the ISTH definition of major bleeding but does meet at least one of the following criteria:

    1. requiring medical intervention by a healthcare professional
    2. leading to hospitalization or increased level of care
    3. prompting a face to face (i.e., not just a telephone or electronic communication) evaluation

    Measured: 6 months

  21. Proprotion of kidney injury

    Proportion of patients with a kidney Injury defined by the Acute Kidney Injury Network (AKIN) definition and classified according to the following stage:

    Stage 1: Serum creatinine increase ≥26.5 μmol/l or increase to 1.5-2.0-fold from baseline Stage 2: Serum creatinine increase >2.0-3.0-fold from baseline Stage 3: Serum creatinine increase >3.0-fold from baseline or serum creatinine ≥354 μmol/l with an acute increase of at least 44 μmol/l or need for new renal replacement therapy.

    Measured: 6 months

  22. Proportion of liver injury

    Proportion of patients with a liver injury defined by elevation of ALT and/or AST ≥3 times the upper limit of normal.

    Measured: 6 months

  23. Proportion of rhabdomyolysis

    Proportion of patients with a rhabdomyolysis defined as muscle symptoms with serum creatinine kinase ≥10 times the upper limit of normal.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2025
  2. Study startApr 2026 (estimated)
  3. Primary completionMay 2027 (estimated)
  4. Study completionNov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06768034
Sponsor's protocol ID
2024-12117
Status last verified
Mar 2026
First submitted
20 Dec 2024
Last updated
19 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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