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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

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

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Centre Hospitalier de l'Université de Montréal — Montreal

Идентификаторы

NCT: NCT06768034 · 2024-12117

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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