NCT01148147已完成3 期
Prevention of Cardiac and Vascular Periprocedural Complications in Patients Undergoing Coronary Angiography or Angioplasty: Intracoronary Adenosine Administration to Prevent Periprocedural Myonecrosis in Elective Coronary Angioplasty. A Prospective Double-blind Randomized Trial.
Azienda Ospedaliero Universitaria Maggiore della Carita1 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2009年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Increase in troponin I (> 3 times the upper normal limit)
研究概览
简要总结
Aim of the study is to evaluate the benefits from adjunctive intracoronary administration of adenosin in elective patients undergoing coronary angioplasty.
详细描述
This study will investigate the effects of adjunctive intracoronary administration of adenosine on periprocedural myocardial infarction as compared to placebo.
This is a double-blind randomized trial single-center study. The enrollment will last 10 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing elective coronary angioplasty
排除标准
- •Marked Bradycardia (< 40 bpm)
- •Previous allergy to adenosine
- •Inability to sign the informed consent
- •Elevated cardiac enzymes (troponin I o CK-MB)
研究组 & 干预措施
Placebo
Placebo Comparator
Intracoronary Placebo administration
干预措施: Placebo (Drug)
Adenosine
Active Comparator
Intracoronary adenosine administration
干预措施: Adenosine (Drug)
结局指标
主要结局
Increase in troponin I (> 3 times the upper normal limit)
时间窗: At 12 hours after the procedure
次要结局
- MACE(death, MI, urgent target-vessel revascularization)(72 hours)
- Angiographic Coronary flow, as evaluated by corrected TIMI frame count.(1 minute after the final stent implantation)
研究者
研究点 (1)
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