Phase 4 Study of Application of Intracoronary Low Dose Streptokinase Complementary to Standard Percutaneous Coronary Intervention in Patients With ST Elevation Acute Myocardial Infarction: Effect of Adjunctive Intracoronary Streptokinase on Late Term Left Ventricular Infarct Size and Volumes in Patients With Acute Myocardial Infarction
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Left ventricular infarct size by SPECT
研究概览
简要总结
The investigators hypothesized that complementary intracoronary streptokinase administration to primary percutaneous intervention in patients with acute myocardial infarction may provide limitation infarct size and improvement in left ventricular volumes and function in acute and late phases (6 months).
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Continuous chest pain that lasted > 30 minutes within the preceding 12 hours
- •ST-segment elevation of at least 1 mm in 2 contiguous leads on the ECG
- •Infarct related artery (IRA) occlusion (TIMI grade 0) at the angiography
排除标准
- •Contraindications to streptokinase, tirofiban, aspirin, clopidogrel, or heparin
- •Culprit lesion in saphenous vein graft
- •TIMI grade II-III flow in IRA
- •Additional epicardial stenosis in the IRA distal to stented segment (significant or insignificant)
- •Presence of left bundle branch block
- •History of prior MI
研究组 & 干预措施
1
Following standard primary percutaneous coronary intervention for ST elevation acute myocardial infarction 250.000 U intracoronary Streptokinase will be given
干预措施: Streptokinase (Drug)
1
Following standard primary percutaneous coronary intervention for ST elevation acute myocardial infarction 250.000 U intracoronary Streptokinase will be given
干预措施: primary percutaneous coronary intervention (Procedure)
2
Standard percutaneous coronary intervention for ST elevation myocardial infarction will be performed
干预措施: primary percutaneous coronary intervention (Procedure)
结局指标
主要结局
Left ventricular infarct size by SPECT
时间窗: at long term (5-6 months)
Left ventricular diastolic volume
时间窗: at long term (5-6 months)
Left ventricular systolic volume
时间窗: at long term (5-6 months)
Left ventricular ejection fraction
时间窗: at long term (5-6 months)
次要结局
- Temporal changes (from baseline to 5 months follow-up) in microvascular perfusion indices (index of microvascular resistance, coronary flow reserve) and in infarct size have been interrogated in only control group.(early phase (at discharge) and late phase (5-6 months))
- Reinfarction(from recruitment until the last follow-up at 5-6 months)
- Major bleeding(from recruitment to discharge)