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

Overview

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.

Interventions

• Procedure Intervention Group
  Patients being referred to an internist or cardiologist after myocardial injury after noncardiac surgery

Primary outcome measures

• Average recruitment rate [Time frame: 12 months]
• Proportion adherence to referral to specialized cardiovascular care in the intervention group [Time frame: 6 months]
• Proportion crossover to referral to specialized CV care in the control group [Time frame: 6 months]

Secondary outcome measures (12)

• Proportion of prescription of cardiovascular medications [Time frame: 6 months]
• Proportion of patients on antiplatelet therapy [Time frame: 6 months]
• Proportion of patients on statin therapy [Time frame: 6 months]
• Proportion of patients on angiotensin-converting enzyme inhibitor (ACEI)/angiotensin II receptor blocker (ARB) [Time frame: 6 months]
• Proportion consent of eligible patients [Time frame: 12 months]
• Proportion of completeness to follow-up [Time frame: 6 months]
• Change in IPAQ score [Time frame: 6 months]
• Change in MEDAS score [Time frame: 6 months]
• Proportion of major cardiovascular events [Time frame: 6 months]
• Proportion of cardiovascular death [Time frame: 6 months]
• Proportion of myocardial infarction [Time frame: 6 months]
• Proportion of non-fatal cardiac arrest [Time frame: 6 months]

Eligibility criteria

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,
• Considered unreliable or unable to complete the trial procedures.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Canada · 1 center

• Centre Hospitalier de l'Université de Montréal — Montreal

Identifiers

NCT: NCT06768034 · 2024-12117

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗