A Randomized Multicenter Trial to Evaluate Early Invasive Strategy for Patients With Acute ST-segment Elevation Myocardial Infarction Presenting 24-48 Hours From Symptom Onset
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 366
- 试验地点
- 1
- 主要终点
- Myocardial infraction size assessed by cardiac magnetic resonance (CMR)
研究概览
简要总结
The primary objective of the trial is to evaluate the efficacy of early invasive strategy for STEMI patients within 24-48h of symptom onset.
详细描述
At present, timely primary percutaneous coronary intervention (PCI) is the preferred strategy for ST-segment elevation myocardial infarction (STEMI) patients within 24h of symptom onset. In stable STEMI patients presenting 12 to 48 hours from symptom onset, BRAVE-2 Trial (n = 365) showed improved myocardial salvage and 4-year survival in patients treated with primary PCI compared with conservative treatment alone. However, data is scarce about the reperfusion strategy focusing on STEMI patients within 24-48h of symptom onset. Further investigations are warranted to explore the best timing of invasive strategy for STEMI patients within 24-48h of symptom onset.
Given that no randomized clinical trial is designed especially for STEMI patients within 24-48h of symptom onset, and limited data is available to evaluate the efficacy of early invasive strategy for the special subgroup of STEMI patients, investigators plan to perform a controlled, randomized trial to evaluate the efficacy of early invasive strategy for STEMI patients within 24-48h of symptom onset.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18 or over and less than 75 years old;
- •ECG: a) ≥2 mm ST-segment elevation in 2 contiguous precordial leads or ≥1 mm ST-segment elevation in 2 contiguous extremity leads; or b) new or presumable new left bundle branch block in the presence of typical symptoms;
- •Patents with STEMI with symptom onset between 24 and 48 hours before randomization;
- •Signed informed consent form prior to trial participation.
排除标准
- •Patents with STEMI with symptom onset <24h or >48h or uncertain time onset.
- •Prior administration of thrombolytic therapy or attempted PCI before randomization;
- •Presence of indications for primary PCI, such as persistent chest pain, cardiogenic shock, life-threatening arrhythmias or cardiac arrest, severe acute heart failure, and mechanical complications;
- •Coagulopathy, active peptic ulcer, history of cerebral or subarachnoid hemorrhage, stroke within 6 months, other contraindications for antiplatelet or anticoagulant therapy;
- •Known intolerance to antiplatelet (e.g. aspirin, clopidogrel, ticagrelor) and anticoagulant therapy (e.g. heparin, bivalirudin);
- •Presence of contraindications for CMR;
- •Congenital heart disease or severe valvular disease;
- •eGFR <30 ml/min/1.73 m2;
- •History of malignant tumors;
- •Combined with other diseases and life expectancy ≤12 months;
- •Inclusion in another clinical trial;
- •Inability to provide informed consent or not available for follow-up judged by investigator.
结局指标
主要结局
Myocardial infraction size assessed by cardiac magnetic resonance (CMR)
时间窗: 7 days (from symptom onset)
Late gadolinium enhancement (LGE) by CMR is performed for myocardial infarction size quantification.
次要结局
- A composite of cardiac death, recurrent myocardial infarction, ischaemia-driven target vessel revascularization, and stoke(30 days)
- Intramyocardial hemorrhage (IMH) assessed by CMR(7 days (from symptom onset))
- Left ventricular end-systolic volume (LVESV) assessed by CMR(7 days (from symptom onset))
- Area at risk (AAR) assessed by CMR(7 days (from symptom onset))
- Left ventricular ejection fraction (LVEF) assessed by CMR(7 days (from symptom onset))
- Left ventricular end-diastolic volume (LVEDV) assessed by CMR(7 days (from symptom onset))
- Microvascular obstruction (MVO) assessed by CMR(7 days (from symptom onset))