POSTconditioning During Coronary Angioplasty in Acute Myocardial Infarction Study (POST-AMI)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Infarct size estimated by magnetic resonance
研究概览
简要总结
The POST-conditioning during coronary angioplasty in Acute Myocardial Infarction (POST-AMI) trial will evaluate the usefulness of postconditioning in limiting infarct size and microvascular damage during the early and late phases after AMI.
详细描述
POST-AMI is a single-center, prospective, randomized trial, with a planned inclusion of 78 patients with ST-elevation Acute Myocardial Infarction (AMI). Patients will be randomly assigned to postconditioning arm (primary angioplasty (PA) and stenting followed by brief episodes of ischemia-reperfusion performed during the first minutes of reperfusion) or non-postconditioning arm (PA and stenting without additional intervention). All patients will be treated medically according to current international guidelines, including glycoprotein IIb/IIIa inhibitors before PCI. The primary end point is to evaluate whether postconditioning, compared to PA without additional intervention, reduces infarct size estimated by magnetic resonance at 30±10 days after the AMI. Secondary end points are microvascular obstruction observed at magnetic resonance, ST-segment elevation resolution, persistent ST-segment elevation, angiographic myocardial blush grade <2 and non sustained/sustained ventricular tachycardia in the 48 hours following PA. Further secondary end points are enzymatic infarct size, left ventricular remodeling and left ventricular function at magnetic resonance performed at 6±1 months, and the reduction of major adverse cardiac events at 30 days and 6 months.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical evidence of myocardial infarction defined by the presence of ischemic chest pain lasting more than 30 minutes, with a time interval from the onset of symptoms less than 6 hours before hospital admission, associated with typical ST-segment elevation on the 12-lead ECG
- •angiographic-detected culprit lesion with stenosis diameter >70% and TIMI flow grade <=1
排除标准
- •previous acute myocardial infarction
- •previous myocardial revascularization (angioplasty or coronary bypass)
- •previous heart valve replacement
- •previous heart transplant
- •clinical instability precluding the suitability of the study
- •cardiogenic shock or persistent hypotension (systolic blood pressure <100 mmHg)
- •rescue angioplasty after thrombolytic therapy
- •evidence of coronary collaterals (Rentrop grade>0) in the risk area
- •advanced atrioventricular block
- •significant bradycardia
- •absence of sinus rhythm
- •inability to lay flat (due to severe cardiac heart failure/respiratory insufficiency)
- •history or clinical evidence of bronchospastic lung disease
- •pregnancy
- •known existence of a life-threatening disease with a life expectancy <6 months
- •inability to give informed consent
- •any contraindication to undergo cardiac-MRI, such as implanted metallic objects (cardiac pacemakers and/or implantable cardioverter defibrillator, implanted insulin pumps or any other type of electronic devices, cerebral clips, aneurysm clips) or any other contraindication to cardiac-MRI (such as claustrophobia)
结局指标
主要结局
Infarct size estimated by magnetic resonance
时间窗: 30±10 days after myocardial infartion
次要结局
- Non sustained/sustained ventricular tachycardia(Within 48 hours after miocardial infarction)
- Enzymatic infarct size(Within 7 days after myocardial infarction)
- ST-segment elevation resolution(First post-intervention ECG)
- Persistent ST-segment elevation(At 24 and 48 hours post-intervention ECG)
- Angiographic myocardial blush grade <2(After primary angioplasty)
- Microvascular obstruction observed at magnetic resonance(30±10 days after myocardial infarction)
- Left ventricular remodeling and left ventricular function at MRI(At 6±1 months)
- Incidence of Major Adverse Cardiac Events (MACE), defined as the combination of death, re-infarction, re-hospitalization for heart failure or repeat revascularization(At 30 days and at 6 months)