Remote Ischemic Preconditioning in ACS Patients
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Ischemic Burden
研究概览
简要总结
Remote ischemic preconditioning is a process of serial blood pressure cuff inflations and deflations that are performed prior to a procedure and have been shown in various other areas (coronary bypass surgery, vascular surgery, ST elevation myocardial infarctions) to decrease the rates of adverse events related to ischemic burden and renal injury. This procedure has not yet been studied in the population presenting with an acute coronary syndrome (ACS), even though ACS patients represent the majority of patients seen in the catheterization lab. The purpose of this study is to evaluate the efficacy of this simple and safe procedure in this particular population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presenting with an acute coronary syndrome including non-ST elevation myocardial infarction or unstable angina on optimal medical therapy with aspirin, P2Y12 inhibitors, unfractionated heparin, statin, +/- beta blocker, +/- ace inhibitor
排除标准
- •Presenting with ST elevation myocardial infarction
- •Patients requiring circulatory support
- •Need for emergent percutaneous coronary intervention
- •Systemic hypotension (systolic blood pressure <90 mmHg)
- •Patients in cardiogenic shock defined by requiring inotropes or vasopressors
- •Patients currently on hemodialysis
- •Presence of an arteriovenous dialysis fistula or graft or lymphedema in either arm
- •Patients enrolled in other active cardiovascular investigational studies
- •Severe comorbidities with a life expectancy of less than 6 months
- •Pregnant or lactating women
- •Patients unable to provide consent
- •Patient taking the medication glibenclamide for treatment of diabetes
结局指标
主要结局
Ischemic Burden
时间窗: 48-72 hours
Assess the impact of remote ischemic preconditioning on myonecrosis following percutaneous coronary intervention by examining pre and post biomarkers
次要结局
- Clinical Outcomes(6 months)
- Renal Injury(48-72 hours)
研究者
Brittany Fuller, MD
Co-Investigator
Henry Ford Health System