NCT00403728Unknown2 期
Protection by Ciclosporine A During Reperfused Acute Myocardial Infarction.
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Infarct size evaluated primarily by the area under the curve of CK and troponin I release over the first 72 hours of reperfusion.
研究概览
简要总结
Beyond its immunosuppressive properties, ciclosporine A (CsA) can also inhibit the opening of a mitochondrial mega-channel called the permeability transition pore (mPTP). Opening of the mPTP plays a key role in cardiomyocyte death during reperfusion following a prolonged ischemic insult. Ciclosporin A has been shown to reduce infarct size when administered at reperfusion in experimental models. The objective of the present study is to determine whether administration of CsA at reperfusion in patients with ongoing acute myocardial infarction treated by coronary angioplasty might reduce infarct size.
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
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients, aged more than 18, with suspected first acute myocardial infarction
- •Within 12 hours of the onset of chest pain
- •With a need for emergency revascularization by angioplasty. Patients must display a fully occluded (TIMI zero flow) culprit coronary artery, absence of visible collaterals and exhibit TIMI flow >2 after direct stenting by angioplasty.
排除标准
- •Hypersensibility to ciclosporine A
- •Cardiac arrest or cardiogenic shock
- •Immunosuppressive disease (< 6 months): cancers, lymphomas, positive serology for HIV, hepatitis, etc.
- •Known renal failure or serum creatinine > 120 µmole/l at admission
- •Liver failure
- •Uncontrolled hypertension
- •Current pregnancy or women without contraception
结局指标
主要结局
Infarct size evaluated primarily by the area under the curve of CK and troponin I release over the first 72 hours of reperfusion.
次要结局
- Myocardial contractile reserve assessed by dobutamine echocardiography at day 5.
- No reflow evaluated by MRI at day 5
- Recovery of myocardial contraction assessed by echocardiography and MRI at month 3
研究者
研究点 (2)
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