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临床试验/NCT01483755
NCT01483755已完成2 期

Delayed Angioplasty Postconditioning in STEMI Patients

Hospices Civils de Lyon10 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2009年7月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
72
试验地点
10
主要终点
Size of the infarct

研究概览

简要总结

The investigators previously reported that angioplasty postconditioning reduces infarct size (cardiac enzyme release) in STEMI patients with a fully occluded coronary artery at hospital admission. Animal studies have suggested that the time window for applying brief episodes of ischemia and reperfusion aimed at triggering postconditioning's protection is very narrow, i.e. does not expand beyond 1 minute after reflow. We sought to address whether this window might be larger in humans, i.e. whether STEMI patients might be protected several minutes after undergoing spontaneous reperfusion before admission coronary angiography.

Therefore, STEMI patients (onset of chest pain less than 12 hours) with a TIMI flow grade > 1 were eligible for that study. Angioplasty postconditioning was completed as already published and infarct size was assessed by measuring cardiac enzymes release.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient > 18 years old
  • Male or female
  • Presenting first myocardial infarction, with the beginning of pains < 12 hours,
  • Requiring a revascularisation by primary angioplasty or " rescue " (after failure of thrombolysis) on LAD or RCA (not Circumflex coronary artery).
  • TIMI flow grade at admission of 2 or 3
  • LV angiography (RAO30°) before angioplasty.

排除标准

  • Cardiac arrest before the angioplasty
  • Cardiogenic shock
  • Occlusion of the artery circumflex responsible for the infarction
  • Visible collaterals to the area at risk
  • Magnetic resonance imaging: contra indication

结局指标

主要结局

Size of the infarct

时间窗: Day 5 post reperfusion

Size of the infarct estimated by magnetic resonance imaging at day 5 post-reperfusion

次要结局

  • Contractile functional recovery(6 months after reperfusion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (10)

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