Clinical trial NCT06768034: SecondarY Prevention and MaNagement of Myocardial Injury AftER Noncardiac SurGerY (SYNERGY) Pilot Trial
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Myocardial Injury After Noncardiac Surgery (MINS)
Keywords: Noncardiac surgery
Secondary cardiovascular prevention
Randomized controlled trial
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2025-01-10
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Average recruitment rate
timeFrame: 12 months
measure: Proportion adherence to referral to specialized cardiovascular care in the intervention group
timeFrame: 6 months
measure: Proportion crossover to referral to specialized CV care in the control group
timeFrame: 6 months
Secondary outcomes:
measure: Proportion of prescription of cardiovascular medications
timeFrame: 6 months
measure: Proportion of patients on antiplatelet therapy
timeFrame: 6 months
measure: Proportion of patients on statin therapy
timeFrame: 6 months
measure: Proportion of patients on angiotensin-converting enzyme inhibitor (ACEI)/angiotensin II receptor blocker (ARB)
timeFrame: 6 months
measure: Proportion consent of eligible patients
timeFrame: 12 months
measure: Proportion of completeness to follow-up
timeFrame: 6 months
measure: Change in IPAQ score
timeFrame: 6 months
measure: Change in MEDAS score
timeFrame: 6 months
measure: Proportion of major cardiovascular events
timeFrame: 6 months
measure: Proportion of cardiovascular death
timeFrame: 6 months
measure: Proportion of myocardial infarction
timeFrame: 6 months
measure: Proportion of non-fatal cardiac arrest
timeFrame: 6 months
measure: Proportion of coronary revascularization
timeFrame: 6 months
measure: Proportion of stroke
timeFrame: 6 months
measure: Proportion of transient ischemic attack
timeFrame: 6 months
measure: Proportion of heart failure
timeFrame: 6 months
measure: Proportion of all-cause mortality
timeFrame: 6 months
measure: Proportion of new significant arrythmia
timeFrame: 6 months
measure: Proportion of major bleeding
timeFrame: 6 months
measure: Proportion of clinically relevant non-major bleeding
timeFrame: 6 months
measure: Proprotion of kidney injury
timeFrame: 6 months
measure: Proportion of liver injury
timeFrame: 6 months
measure: Proportion of rhabdomyolysis
timeFrame: 6 months
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal
state: Quebec
Study officials:
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
name: Emmanuelle Duceppe, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: