Late Reperfusion With Percutaneous Coronary Intervention in Patients With ST-segment Elevation Myocardial Infarction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Acute salvage index evaluated by MRI
研究概览
简要总结
Although recommended therapy for patients with ST-segment elevation myocardial infarction is primary PCI, it remains unestablished whether patients with a symptom duration of more 12 hours benefit from acute revascularisation.
This study aims to investigate whether acute intervention is superior to subacute intervention in these patients.
详细描述
The recommended therapy for patients with ST-segment elevation myocardial infarction (STEMI) is to restore normal coronary blood flow with timely reperfusion by percutaneous coronary intervention (PCI), and thereby minimize the extent of cell death and preserving cardiac function. The duration of ischemia and timely PCI are major determinants for the size of the myocardial infarction and prognosis. Thus, acute PCI should be performed within 12 hours after symptom onset. The effect of PCI and timing of PCI are, however, much more uncertain for late presenters who contact the health service > 12 hours from symptom. Thus, it is still unknown whether late presenters should be treated with acute PCI or medical treatment with delayed PCI (24-72 h after first medical contact).
The study investigates the effect on final salvage index evaluated by magnetic resonance imaging of acute PCI of late presenters.
The overall objective of the study is to investigate whether late presenters may benefit from acute PCI, and thus whether to extend the currently recommended time limit of 12 hours for acute PCI in patients with STEMI.
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 (Outcomes Assessor)
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
- •Inclusion criteria:
- •Patients more than 18 years of age.
- •STEMI > 12 hours and < 36 hours.
- •Clinical stable, i.e. no on going angina, hemodynamically stable (systolic BP > 90) and Killip class < 3.
排除标准
- •Clinical instability which requires an acute invasive strategy.
- •Left main occlusion or multivessel disease which requires CABG.
- •Previous Q-wave infarction in the current infarct related artery.
- •Left Bundle Branch Block (LBBB).
- •Severe renal insufficiency.
- •Pacemaker
- •Chronic atrial fibrillation.
- •Previous Coronary Artery Bypass Surgery (CABG).
- •Pregnancy.
- •Other severe illness with life expectancy less than 1 year
研究组 & 干预措施
Acute PCI
Acute re-opening of the occluded coronary artery including premedication as for primary PCI within 12 hours
干预措施: PCI (Procedure)
Subacute PCI
Standard subacute re-opening of the occluded coronary artery including premedication as for subacute PCI within 72 hours
干预措施: PCI (Procedure)
结局指标
主要结局
Acute salvage index evaluated by MRI
时间窗: 1-2 days
MRI within 48 timer after index admission will be used to measure are at risk (AAR, T2-weighted) and acute infarct size (IZ). Acute salvage index is (AAR-IZ)/AAR
次要结局
- Final infarct size(3 months)
- Microvascular obstruction (MVO)(1-2 days)
- Final myocardial salvage index(1-2 days)
- Left Ventricular Ejection Fraction (LVEF)(1-2 days and 3 months)
- Acute infarct size(1-2 days)
研究者
Thomas Engstrom
Chief Consultant
Rigshospitalet, Denmark