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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Average recruitment rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Average recruitment rate
时间窗: 12 months
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".
Proportion adherence to referral to specialized cardiovascular care in the intervention group
时间窗: 6 months
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".
Proportion crossover to referral to specialized CV care in the control group
时间窗: 6 months
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".
次要结局
- Proportion of prescription of cardiovascular medications(6 months)
- Proportion of patients on antiplatelet therapy(6 months)
- Proportion of patients on statin therapy(6 months)
- Proportion of patients on angiotensin-converting enzyme inhibitor (ACEI)/angiotensin II receptor blocker (ARB)(6 months)
- Proportion consent of eligible patients(12 months)
- Proportion of completeness to follow-up(6 months)
- Change in IPAQ score(6 months)
- Change in MEDAS score(6 months)
- Proportion of major cardiovascular events(6 months)
- Proportion of myocardial infarction(6 months)
- Proportion of non-fatal cardiac arrest(6 months)
- Proportion of coronary revascularization(6 months)
- Proportion of stroke(6 months)
- Proportion of transient ischemic attack(6 months)
- Proportion of heart failure(6 months)
- Proportion of cardiovascular death(6 months)
- Proportion of all-cause mortality(6 months)
- Proportion of new significant arrythmia(6 months)
- Proportion of major bleeding(6 months)
- Proportion of clinically relevant non-major bleeding(6 months)
- Proprotion of kidney injury(6 months)
- Proportion of liver injury(6 months)
- Proportion of rhabdomyolysis(6 months)
研究者
Emmanuelle Duceppe MD PhD
Scientist
Centre hospitalier de l'Université de Montréal (CHUM)