Mild Therapeutic Hypothermia for Patients With Acute Coronary Syndrome and Cardiac Arrest Treated With Percutaneous Coronary Intervention
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Jacek Kubica
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- All cause mortality
研究概览
简要总结
Mild Therapeutic Hypothermia for Patients with Acute Coronary Syndrome and Cardiac Arrest Treated with Percutaneous Coronary Intervention (UNICORN) study is designed to determine whether mild therapeutic hypothermia (MTH) applied in patients with acute coronary syndromes (ACS) and cardiac arrest treated with percutaneous coronary intervention (PCI) is associated with better clinical outcomes as compared with therapy without MTH.
详细描述
The UNICORN study is a multi-center, international, observational, phase IV clinical trial which is aimed to investigate whether MTH applied in patients with ACS and cardiac arrest treated with PCI is associated with better clinical outcomes as compared with therapy without MTH. This trial will provide important information regarding the impact of MTH in unconscious with a score of ≤8 on the Glasgow Coma Scale on admission to the hospital after out-of-hospital cardiac arrest (OHCA) with diagnosed or presumed ACS and shockable initial rhythm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Survivor of OHCA
- •Sustained return of spontaneous circulation (ROSC) for more than 20 minutes after resuscitation
- •Unconsciousness with a score of ≤8 on the Glasgow Coma Scale after ROSC
- •Shockable initial rhythm
- •Diagnosis or suspicion of ACS
排除标准
- •Unwitnessed OHCA
- •Obvious or suspected pregnancy
- •Known serious infection/sepsis before OHCA
- •Known bleeding diathesis
- •Confirmed or suspected internal bleeding
- •Confirmed or suspected acute stroke
- •Confirmed or suspected cerebral injury
- •Known serious neurological dysfunction (CPC≤4) before OHCA
- •Known serious disease making 180 days of survival unlikely
- •Hemodynamic instability with systolic blood pressure <65 mmHg despite treatment
- •Time delay from ROSC to MTH induction > 240 min.
- •Asystole or pulseless electrical activity (PEA) as the initial rhythm
- •Initial body temperature <30°C
结局指标
主要结局
All cause mortality
时间窗: 180 days
次要结局
- Early stent thrombosis(30 days)
- Neurological outcome according to Cerebral Performance Category (CPC)(at discharge (up to 180 days))
- Infectious complications(180 days)
- Rhythm and conductions disorders(180 days)
- Bleedings according to the Bleeding Academic Research Consortium (BARC) criteria(180 days)
研究者
Jacek Kubica
Head of Cardiology, Principal investigator
Collegium Medicum w Bydgoszczy