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临床试验/NCT00409604
NCT00409604已完成2 期

Clinical Evaluation of Pacing During the Onset of Revascularization / Feasibility Study

Guidant Corporation1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2006年12月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
60
试验地点
1
主要终点
Infarct size (area under the curve of creatine kinase) at baseline compared with MRI at 4 months and at 12 months

研究概览

简要总结

To determine whether the application of ventricular pacing can protect the human heart from damage resulting from a myocardial infarction

详细描述

To determine whether the application of ventricular pacing can protect the human heart from damage resulting from a myocardial infarction

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

  • Clinical diagnosis of acute myocardial infarction, requiring PCI within 2 to 6 hours following symptoms
  • Total occlusion of a coronary artery with reference vessel diameter >or= 3mm

排除标准

  • Thrombolitics
  • Severe bradycardia requiring cardiac pacing
  • Previous PCI or CABG
  • Recent stroke or CV surgery
  • Recent major surgery or trauma
  • Clinical and hemodynamic unstability
  • Implanted CRM device
  • Evidence of previous MI
  • Diabetes using rosiglitazone or other fibrates
  • Permanent AF
  • Mechanical tricuspid valve
  • Pregnancy
  • Exclusion for MRI
  • Incapability of participating in exercise test

结局指标

主要结局

Infarct size (area under the curve of creatine kinase) at baseline compared with MRI at 4 months and at 12 months

时间窗: 4 & 12 months

次要结局

未报告次要终点

研究者

申办方类型
Industry

研究点 (1)

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