Clinical and MRI Evaluation of 2 Vs 4 Cycles of Postconditioning During Primary PCI With Direct Stenting
试验速览
- 阶段
- 不适用
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- ST segment resolution.
研究概览
简要总结
To determine the safety and efficacy of 2 vs 4 cycles of postconditioning method during primary PCI and direct stenting in acute MI, and to compared to primary PCI and direct stenting without the postconditioning.
详细描述
Sample size: 45 subjects
Site Locations: Sheba medical center
Patients: Patients presenting with an acute MI with onset of symptoms 6h, and planned to undergo primary PCI will be included. The target lesion should be located in the proximal or middle segment of a main native coronary artery, and should be suitable for percutaneous intervention.
Primary Objective: To determine the safety and efficacy of 2 vs 4 cycles of postconditioning method during primary PCI and direct stenting in acute MI, and to compared to primary PCI and direct stenting without the postconditioning.
Primary Endpoint:
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
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is > 21 years of age and provides informed consent.
- •Evidence of AMI as indicated by signs and symptoms. Diagnosis of ST-segment elevation AMI will be based on chest pain for >30 minutes and ST-segment elevation of >1mV in 2 limb lead or >2mV in 2 anterior leads contiguous leads on the 12-lead ECG.
- •Eligible to undergo primary PCI.
- •Symptom duration is < 6 hours prior to primary PCI.
- •Angiographic: The target lesion in the infarct related artery (IRA) should be occluded (TIMI).
- •Angiographic: The target lesion in the proximal or middle segment of a native major coronary artery (LAD, RCA or dominant CX).
- •Angiographic: The target lesion should be suitable for PTCA or stenting.
- •Angiographic: The IRA occlusion will be successfully opened by stenting with TIMI 2-3
排除标准
- •Unwillingness to participate.
- •Prior Acute MI
- •Cardiac arrest or Killip score III-IV
- •Women with known pregnancy.
- •Active significant bleeding.
- •Known allergy for aspirin, ticlopidine and clopidogrel, or heparin.
- •Chronic renal failure with creatinine > 2 mg/dl
- •Other medical illness associated with limited life expectancy or that may cause the patient to be non-compliant with the protocol.
- •Current participation in other trials using investigational drugs or devices.
- •Contraindications to MRI including: arrythmias, cardiac pacer, brain aneurysm clips, cochlear implants, nerve stimulator.
结局指标
主要结局
ST segment resolution.
Segmental wall motion score, resolution of edema and wall thickness by echocardiography.
Infarct size estimation by cardiac enzymes and cardiac MRI.
次要结局
- Composite endpoint of Major Adverse Cardiac Events (MACE) at 30 and 90 days