NCT01218815终止不适用
Complete Infarct Related Artery Revascularization in Acute Myocardial Infarction Patients - CORAMI Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 18
- 主要终点
- ST resolution in ECG (electrocardiogram) and MBG (myocardial blush grade)
研究概览
简要总结
CORAMI trial is a prospective, international, multicenter randomized study which will be performed in experienced invasive facility centres with 24/7 PCI (percutaneous coronary intervention) duty and patient enrollment will continue for 18 months (October 2010 - March 2012).The aim of the study is to compare strategy of complete vs target lesion-only primary PCI in IRA (infarct related artery) in STEMI (ST elevation myocardial infarction) patients.
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
- •diagnosis of STEMI (according to ESC 2007 definition)
- •Chest pain onset <12 hours
- •signed informed consent
- •Presence of two critical lesions requiring PCI in IRA (LAD - left anterior descending, Cx - circumflex, RCA - right coronary artery)
- •Target/culprit lesion which requires immediate stenting (>50 - 100%) and second critical lesion (70-90%) with TIMI 3 flow after PCI of the 1st target/culprit lesion
- •Over 18 years of age
- •IRA diameter ≥ 2.5 mm
排除标准
- •Terminal illness with life expectancy less <1 year or active cancer disease - Pregnancy or possibility of pregnancy
- •Second critical lesion in IRA >90% or occlusion
- •Contraindications to PCI or/and stent implantation
- •Contraindications to DES stent implantation
- •Lesion diameters unsuitable for intended stent platform
- •Active bleeding or coagulopathy
- •Patient in cardiogenic shock (<90mmHg SBP and/or requiring IABP - intraaortic balloon pump - or vasopressors) - Killip 4 class
- •Patient has Left Bundle Branch Block (LBBB) or pacemaker rhythm
- •No future patient cooperation expected
- •Patient is participating in another clinical study
结局指标
主要结局
ST resolution in ECG (electrocardiogram) and MBG (myocardial blush grade)
时间窗: in-hospital directly after PCI
This is a combined end-point of ST - segment resolution \>70% assessed directly after PCI + MBG 3 assessed directly after PCI (assessments by ECG and QCA Corelab).
次要结局
- Clinical major ischemic events(12-months)
- Adverse events and complications during hospital stay(during patient index hospitalization (up to 7 days))
研究者
研究点 (18)
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