Local Delivery of thrombolytIcs Before Thrombectomy in patientS With ST-elevatiOn myocardiaL Infarction Undergoing Primary percuTaneous Coronary interventION - The DISSOLUTION Randomized Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 主要终点
- Outcomes at 30 days
研究概览
简要总结
Background Prompt reperfusion with percutaneous coronary intervention (PCI) in the setting of ST-elevation myocardial infarction (STEMI) improves clinical outcomes through salvage of myocardial tissue.
Although the use of thrombus aspiration with PCI can result in improved rates of normal epicardial flow and myocardial perfusion, several unmet needs remain.
Purpose The purpose of this trial will be to evaluate the hypothesis that local delivery of thrombolytics vs. saline infusion prior to thrombus aspiration and PCI is safe and effective in patients with STEMI.
详细描述
The study will select patients with ST-elevation myocardial infarction (STEMI) with angiographic evidence of massive thrombosis in the culprit artery undergoing manual thrombectomy followed by primary percutaneous coronary intervention (PCI).
Patients will be randomized to receive local bolus of 200,000 units urokinase or saline solution
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •ST-elevation myocardial infarction
- •angiographic evidence of massive thrombosis in the culprit artery
- •Indication to manual thrombectomy followed by primary percutaneous coronary intervention (PCI)
- •Able to understand and willing to sign the informed CF
排除标准
- •Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before CT
研究组 & 干预措施
Urokinase
Patients will be randomized to to receive local bolus of 200,000 units urokinase
干预措施: Urokinase (Drug)
Saline
Patients will be randomized to to receive local bolus of intracoronary saline
干预措施: Saline (Drug)
结局指标
主要结局
Outcomes at 30 days
时间窗: Up to 30 days
30-day occurrence of death, new Q-wave myocardial infarction, coronary artery bypass grafting, target lesion revascularization, stroke, or stent thrombosis
次要结局
- Left ventricular remodeling(Up to 1 year after Primary PCI)
- Myocardial reperfusion after Primary CI(Up to 90 minutes after Primary PCI)
- 5-year MACE(Up to 5 years after Primary PCI)
研究者
Francesco Pelliccia
Assistant Professor
University of Roma La Sapienza