SecondarY Prevention and maNagement of Myocardial Injury aftER Noncardiac surGerY (SYNERGY) Pilot… (NCT06768034) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
SecondarY Prevention and maNagement of Myocardial Injury aftER Noncardiac surGerY (SYNERGY) Pilot Trial
Canada100 participantsStarted 2026-04
Plain-language 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.
Who can participate
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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,
What they're measuring
1
Average recruitment rate
Timeframe: 12 months
2
Proportion adherence to referral to specialized cardiovascular care in the intervention group
Timeframe: 6 months
3
Proportion crossover to referral to specialized CV care in the control group