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临床试验/NCT01158716
NCT01158716已完成不适用

Remote Ischemic Preconditioning in ad Hoc Percutaneous Coronary Interventions: a Randomized Clinical Study

Cardiovascular Research Society, Greece2 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2011年7月1日最近更新:
适应症
干预措施

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

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

Active Comparator

干预措施: Remote Ischemic Preconditioning (Other)

Control

No Intervention

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

发起方
Cardiovascular Research Society, Greece
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr D Katritsis

Head of Department of Cardiology, Athens Euroclinic

Cardiovascular Research Society, Greece

研究点 (2)

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