Distal Protection Device Did Not Improve Microvascular Obstruction Evaluated by Cardiac MR After Primary Percutaneous Intervention for ST-elevation Myocardial Infarction
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Postinfarct Remodeling
研究概览
简要总结
The investigators examined the mechanism underlying the lack of benefit from distal protection and thrombus aspiration (DP-TA) in 126 patients with ST-elevation Myocardial Infarction (STEMI) in a prospective, randomized trial.
详细描述
Patients with first-diagnosed STEMI were randomly assigned to distal protection and thrombus aspiration (DP-TA) pretreatment during percutaneous coronary intervention (PCI) or conventional PCI (c-PCI).
The primary endpoint was the remodeling index (RI), measured by cardiac magnetic resonance imaging (CMR) post-PCI and 6 months after PCI.
Secondary endpoints, determined by CMR within 3 to 5 days after PCI, included the infarct ratio (infarct size to entire left ventricular [LV] size ) by delayed-enhancement (DE), area at risk (AAR) ratio (AAR to LV size) by T2 high-signal intensity , microvascular occlusion index (MVO) ratio (MVO to LV size) by DE, and myocardial salvage index (MSI, [AAR-infarct size] x 100/AAR).
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 (Participant)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •30 and less than 80 years presenting with STEMI
- •more than 30 minutes but less than 12 hours after symptom onset
- •with ≥ 2 mm of ST-segment elevation in 2 or more contiguous leads or with a presumably new left bundle-branch block
- •for whom primary PCI was intended
排除标准
- •included thrombolytic therapy before PCI;
- •spontaneous restoration of coronary flow (> TIMI grade II or III);
- •cardiogenic shock (Killip class IV);
- •major surgery or active bleeding within 6 weeks;
- •aspirin, thienopyridine, or heparin allergy;
- •neutropenia (<1000 neutrophils/mm3), thrombocytopenia (<100000 platelets/mm3), hepatic dysfunction, or renal insufficiency (serum creatinine level >2.5 mg/dL [221 μmol/L]);
- •noncardiac condition with expected survival less than 1 year;
- •current participation in other investigations.
研究组 & 干预措施
DP-TA
distal protection and thrombus aspiration during primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI)
干预措施: distal protection and thrombus aspiration (The GuardWire Plus (Medtronic Inc.)) (Device)
c-PCI
conventional PCI without DP-TA during primary percutaneous coronary intervention for ST-elevation myocardial infarction
干预措施: c-PCI (Procedure)
结局指标
主要结局
Postinfarct Remodeling
时间窗: 6 months
postinfarct remodeling as evidenced by decreased left ventricular (LV) dilatation measured by CMR 6 months post PCI
次要结局
- Reperfusion Success(3-5 days)
研究者
Dong-Ju Choi
director of cardiovascular center
Seoul National University Bundang Hospital