Remote Ischemic Preconditioning in ad Hoc Percutaneous Coronary Interventions: a Randomized Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- Delta Cardiac Troponin I (ΔcTnI)
研究概览
简要总结
Elective percutaneous coronary intervention (PCI) is associated with troponin release in approximately one third of cases. Myocardial necrosis may result from downstream embolization of atheromatous material, coronary side-branch occlusion and may involve ischemia/reperfusion injury. The investigators hypothesized that a single remote ischemic preconditioning cycle would reduce peri-procedural troponin release.
详细描述
Elective percutaneous coronary intervention (PCI) is associated with troponin release in approximately one third of cases, which is a sensitive and specific marker of myocyte necrosis. Myocardial necrosis may result from downstream embolization of atheromatous material, coronary side-branch occlusion and may involve ischemia/reperfusion injury. A number of studies have demonstrated that procedure-related troponin release is associated with subsequent cardiovascular events and a worst prognosis, especially in those patients with the most marked elevation in troponin concentration.
Recently, 3 cycles of 5-minute ischemia followed by 5-minute reperfusion of the upper extremities were shown to reduce troponin release in elective PCI. However, this ischemic preconditioning (IPC) protocol requires 30 minutes and is of limited use in the context of PCI at the time of initial cardiac catheterization (ad hoc coronary intervention).
Since experimental evidence suggests that IPC is a graded than an "all-or-nothing" phenomenon, and even a short, single IPC cycle may have protective effects in the myocardium, the investigators hypothesized that patients undergoing ad hoc coronary intervention would have reduced peri-procedural troponin release if subjected to a single, remote IPC cycle, between diagnostic catheterization and coronary intervention.
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
- 年龄范围
- 18 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a significant stenosis as documented in coronary angiography eligible for PCI
- •Patients ≥ 18 of age and able to give informed consent
排除标准
- •Severe comorbidity (estimated life expectancy <6 months)
- •Use of nicorandil or glibenclamide
- •Elevated baseline cTnI before PCI
- •Renal disease as documented by serum creatinine before PCI
- •LVEF<35%
研究组 & 干预措施
Remote Ischemic Preconditioning
干预措施: Remote Ischemic Preconditioning (Other)
Control
结局指标
主要结局
Delta Cardiac Troponin I (ΔcTnI)
时间窗: 24 hours post PCI
ΔcTnI is defined as cardiac troponin I (cTnI) at 24 hours post-PCI minus cTnI before coronary angiography
次要结局
- Chest Pain During Coronary Balloon Occlusion(During coronary balloon occlusion)
- ECG Evidence of Ischemia During Coronary Balloon Occlusion(During coronary balloon occlusion)
研究者
Dr D Katritsis
Head of Department of Cardiology, Athens Euroclinic
Cardiovascular Research Society, Greece
