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.
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
- Conditions the study is for
- Myocardial Injury After Noncardiac Surgery (MINS)
- 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
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Intervention Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
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)
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
Proportion of patients on antiplatelet therapy
Proportion of patients who are prescribed an antiplatelet therapy.
Measured: 6 months
Proportion of patients on statin therapy
Proportion of patients who are prescribed a statin.
Measured: 6 months
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
Proportion consent of eligible patients
Proportion of eligible patients which consented to participate in the trial
Measured: 12 months
Proportion of completeness to follow-up
Proportion of patients enrolled in the trial that completed the 6-month follow-up
Measured: 6 months
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
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
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
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
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
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
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
Proportion of stroke
Proportion of patients with a stroke defined as either:
- 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
- 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
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
Proportion of heart failure
Proportion of patients with a diagnosis of heart fialure, as defined by (criteria A and B required):
- New or worsening symptoms due to heart failure (HF), including at least ONE of the following:
- Shortness of breath (dyspnea with exertion, dyspnea at rest, orthopnea, paroxysmal nocturnal dyspnea), 2. Decreased exercise tolerance, or 3. Fatigue.
- 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
Proportion of all-cause mortality
Proportion of patients who died of any cause.
Measured: 6 months
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
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:
- a fall in hemoglobin level of 2 g/dL or more or documented transfusion of at least 2 units of packed red blood cells,
- involvement of a critical anatomical site (intracranial, spinal, ocular, pericardial, articular, intramuscular with compartment syndrome, retroperitoneal).
Measured: 6 months
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:
- requiring medical intervention by a healthcare professional
- leading to hospitalization or increased level of care
- prompting a face to face (i.e., not just a telephone or electronic communication) evaluation
Measured: 6 months
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
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
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.
- First posted10 Jan 2025
- Study startApr 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial Injury After Noncardiac Surgery (MINS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada
- Responsible party
- Sponsor
- Investigators
- Emmanuelle Duceppe, MD PhD, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
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