NCT00846222Unknown3 期
Adjunctive Mild Hypothermia Therapy to Primary Percutaneous Coronary Intervention in Patients With Acute Myocardial Infarction Complicated With Shock: A Feasibility Study
适应症
干预措施
试验速览
- 阶段
- 3 期
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Primary en point: presence of major adverse cardiac events (MACE) MACE definition: death and non-fatal re-infarction.
研究概览
简要总结
The purpose of this study is evaluate the safety and feasibility of mild therapeutic hypothermia (TH) during and 12 hours after primary percutaneous coronary intervention for acute myocardial infarction complicated with shock
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 88 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recent myocardial infarction: 24 hours of start pain
- •Pump failure cardiogenic shock (defined as persistent hypotension, systolic BP < 90 mmHg, despite fluids and catecholamines infusion, with tissue hypoperfusion signs
- •Candidate for immediate percutaneous reperfusion
- •Maximal care support: mechanical ventilation, intraaortic balloon contrapulsation
排除标准
- •Cardiogenic shock related to mechanical complication: free wall rupture, acute mitral regurgitation, acute VSD, tamponade
- •Pregnant women
- •Absence of maximal support care
研究组 & 干预措施
Mild theraputic hypothermia
Experimental
干预措施: Hypothermia (Procedure)
结局指标
主要结局
Primary en point: presence of major adverse cardiac events (MACE) MACE definition: death and non-fatal re-infarction.
时间窗: 30 days
次要结局
- Infarct size calculated by area under thr curve creatinine kinase according consecutive samples Reversal stunning by blinded observer echocardiographic assessment(30 days)
研究者
研究点 (1)
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