Complete Infarct Related Artery Revascularization in Acute Myocardial Infarction Registry(CORAMIreg)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 7
- 主要终点
- Death
研究概览
简要总结
Objective of this registry study is to compare strategy of complete vs. target lesion-only primary PCI (percutaneous coronary intervention) in IRA (infarct related artery) in STEMI (ST elevation myocardial infarction) patients.
详细描述
CORAMI is a registry study addressing the issue of complete vs culprit-only PCI within infarct related artery in patients with ST-elevation and non-ST elevation myocardial infarction treated with interventional procedures.
The main objectives of the study include:
- gathering data on patients with at least two independent critical stenotic lesions in IRA (one of which is the culprit lesion) during index primary PCI for STEMI or NSTEMI (prevalence, characteristic, predisposing factors).
- comparing chosen treatment strategies for multiple lesion IRA
- comparison of complete vs. target lesion-only PCI in IRA in acute MI (myocardial infarction) patients.
The study clinical hypothesis is that stenting single critical - culprit lesion in multi-lesion IRA in MI patients during index PCI procedure is superior to stenting all critical lesions in IRA in terms of early treatment result and might be associated with less frequent periprocedural angiographic complications.
H0: The efficacy in terms of early treatment result of stenting one critical - culprit lesion in multilesions IRA in acute MI patients is less or equal to efficacy of stenting all critical lesions in IRA.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
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 or NSTEMI (according to ESC 2007 definition)
- •Over 18 years of age
- •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%).
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
- •Con-current participation in another clinical study that did not meet its primary end-point
结局指标
主要结局
Death
时间窗: At 12 months
Death rates at 12-month clinical follow-up
Stent thrombosis
时间窗: At 12 months
Rates of stent thrombosis at 12-month follow-up according to ARC definition
reMI (repeat myocardial infarctions)
时间窗: At 12 months
Rates of reMI at 12 months
urgent TVR (target vessel revascularization) at 12 months
时间窗: 12 months and at 12 months
Rates of urgent TVR at 12 months
Planned TVR
时间窗: At 12 months
Rates of planned TVR (PCI + CABG) at 12 months
次要结局
- Angiographic complications(During hospitalization)
- Target Vessel Revascularization (PCI and/or CABG (coronary artery bypass graft))(During hospitalization and at 12 months)
- Complete contrast dose in ml(During hospitalization and at 12 months)
- Complete radiation dose in mGy(During hospitalization and at 12 months)