The Mechanism of Ischemic Post-conditioning in Humans: Minimizing Reperfusion Injury in Patients With Acute Myocardial Infarction
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Quantitation of infarct size will be done using a modification of University Hospital's standard Single-photon emission computed tomography (SPECT) quantitation software
研究概览
简要总结
The size of a heart attack will be decreased by the use of timed balloon inflations to open the blocked blood vessel.
详细描述
The intervention of "post conditioning" at the time of reperfusion, in patients with acute myocardial infarction (AMI), will attenuate the degree of ischemia-reperfusion injury, as manifested by infarct size. This intervention is hypothesized to be safe in humans.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Onset of symptoms within 6 hours
- •TIMI 0 to TIMI 1 flow in infarct related artery
排除标准
- •collaterals to infarct related artery
- •previous infarct in related territory
- •thrombolytics
- •cardiogenic shock
- •TIMI 2 to TIMI 3 flow
结局指标
主要结局
Quantitation of infarct size will be done using a modification of University Hospital's standard Single-photon emission computed tomography (SPECT) quantitation software
时间窗: 6 weeks
Echocardiograms will be analyzed to evaluate left ventricular function. Standard techniques will be used to quantitate ejection fraction and the percentage of left ventricular circumference that is hypokinetic or dyskinetic.
时间窗: 6 weeks
Venous blood samples troponin, creatine phosphokinase (CPK). This will be done to follow enzyme release and washout, and area data will be available and infarct size/risk area ratios in control and post-conditioning subjects will be compared.
时间窗: baseline, every 8 hours x 3
ECG ST segment resolution immediate post percutaneous coronary intervention(PCI), and daily x 3.
时间窗: baseline, up to 3 days
次要结局
未报告次要终点
研究者
Tarek Helmy
Professor
University of Cincinnati