VELOCITY: Pilot Study to Evaluate Ultrafast Hypothermia Before Reperfusion in Patients With Acute ST-Elevation Myocardial Infarction
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 54
- 试验地点
- 11
- 主要终点
- Composite of new-onset SAEs
研究概览
简要总结
This study will look at the safety of treating patients with heart attack with mild hypothermia induced using a system of automated peritoneal lavage. The hypothesis is that the Velomedix Automated Peritoneal Lavage System can treat patients with heart attack safely and with adequate performance.
详细描述
The study aims to determine the safety and feasibility of using the Velomedix Automated Peritoneal Lavage System to treat patients with STEMI using therapeutic hypothermia. Patients will undergo cooling, maintenance and rewarming and applicable data will be gathered on device performance and patient safety. Patient temperature and vital signs will be monitored in addition to various laboratory values. Adverse event reporting will take place at multiple time intervals and follow-up will continue out to 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
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical symptoms consistent with acute STEMI lasting at least 30 minutes
- •STEMI with ST-Elevation of ≥2 mm in two or more contiguous ECG leads
- •Patient eligible for PCI
排除标准
- •Cardiac arrest with return of spontaneous circulation
- •Known prior history of MI
- •Known history of severe COPD requiring supplemental home oxygen
- •Patient experiencing intractable cardiogenic shock, or requiring immediate placement of a mechanical cardiac assist device
- •Known severe anemia or abnormal platelet count
- •Known significant renal insufficiency
- •Known contraindication for MRI
- •Known contraindications to hypothermia, such as temperature-sensitive hematological dyscrasias or vasospastic disorders
研究组 & 干预措施
Therapeutic Hypothermia Treatment
干预措施: Velomedix APLS device (Device)
No Hypothermia Treatment
control group is no hypothermia treatment
干预措施: No Hypothermia Treatment (Other)
结局指标
主要结局
Composite of new-onset SAEs
时间窗: 30 days
Composite of new-onset serious adverse events, specifically death, ischemia driven target vessel revascularization (TVR), recurrent MI, pneumonia, sepsis, ventricular tachycardia or fibrillation requiring cardioversion, renal failure, peritonitis and significant bleeding.
次要结局
- MACE rate(30 days)
- All cause mortality(6 months)
- Myocardial infarct size(3 days)