Direct or Subacute Coronary Angiography in Out-of-hospital Cardiac Arrest - a Prospective, Randomized Study
概览
- 阶段
- 不适用
- 干预措施
- Immediate coronary angiography
- 疾病 / 适应症
- Out-of-Hospital Cardiac Arrest
- 发起方
- Uppsala University
- 入组人数
- 1003
- 试验地点
- 32
- 主要终点
- 30 day survival
- 状态
- 已完成
- 最后更新
- 24天前
概览
简要总结
The overall aim of this prospective, randomized study is to investigate whether acute coronary angiography (within 120 minutes) with a predefined strategy for revascularization, will improve 30-day survival in patients with out of hospital cardiac arrest with no signs of ST-elevation on ECG after Restoration of Spontaneous Circulation (ROSC). The patients will be randomized to a strategy of immediate coronary angiography within 120 minutes or to a strategy of delayed angiography that may be performed three days after the cardiac arrest.
详细描述
The study is a prospective randomized open label multicenter study with a registry follow up in which patients with out of hospital cardiac arrest without ST-elevation on their first ECG will be randomized to either a strategy of immediate coronary angiography (treatment group) with possible coronary intervention or a strategy of delayed coronary angiography (control group). The study will include in total 1006 patients with Restoration of Spontaneous Circulation (ROSC). Randomization will be done via a web-based module after ECG is taken at the first medical contact but no later than after arrival at the emergency room. Coronary angiography should be performed within 120 minutes from randomization in the immediate angiography group. In the delayed angiography group, angiography with possible coronary intervention will be performed at the discretion of the interventional cardiologist and should preferably not be performed until three days after the cardiac arrest. This strategy is in accordance with standard practice. In case of recurrent chest pain, ST elevation, circulatory instability or cardiogenic shock, cross over to early angiography may occur. The quality of life and health economics will be evaluated at 6 months. The patients will undergo extensive neurocognitive tests and health instruments, these will be analyzed and presented.
研究者
入排标准
入选标准
- •Witnessed out of hospital cardiac arrest
- •Restoration of Spontaneous Circulation (ROSC) \>20 minutes
- •Coronary angiography is expected to be performed within 120 minutes from inclusion and randomization at hospital
排除标准
- •Patient age \<18 years
- •Obvious extracardiac genesis of cardiac arrest such as trauma, hemorrhagic shock, and / or asphyxia (eg drowning, suffocation, hanging, exposure to fire smoke)
- •Terminally ill patients with a life expectancy of less than 1 year
- •Patients with ST-elevation
- •Known pregnancy
- •Patient awake GCS \>8 (Glasgow Coma Scale)
研究组 & 干预措施
Immediate coronary angiography
Immediate coronary angiography for out of hospital cardiac arrest patients with no signs of ST elevation on their first ECG after ROSC
干预措施: Immediate coronary angiography
Not immediate coronary angiography
Coronary angiography with possible coronary intervention may be performed at the discretion of the interventional cardiologist and should preferably not be performed until three days after the cardiac arrest. This strategy is in accordance with standard practice.
结局指标
主要结局
30 day survival
时间窗: 30 days
Follow up will be performed at 30 days, telephone call or visit.
次要结局
- Survival with good neurological function(30 days)
- Survival at discharge from ICU (individual for each subject) and at 6-months(At discharge from ICU, an expected average of 3-30 days and at 6-months)
- Cardiac function(72 hours and at 6 months)
- Survival with good neurological function at discharge from ICU and 6-months(At discharge from ICU, an expected average of 3-30 days and at 6-months)
- Follow up of neurological function at 6-months(Measured at 6 months)
- ECG findings compared to findings at coronary angiography(During hospital stay up to a maximum of 6-months)
- Hemodynamic parameters (urine output, highest lactate and vasopressor/inotropic support)(During ICU care (maximum of 7 days))