Immediate Unselected Coronary Angiography Versus Delayed Triage in Survivors of Out-of-hospital Cardiac Arrest Without ST-segment Elevation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 558
- 试验地点
- 2
- 主要终点
- All-cause mortality
研究概览
简要总结
The aim of the trial is to compare immediate angiography in survivors of out of hospital cardiac arrest (OHCA) without ST-segment elevation versus delayed/selective catheterization with respect to 30 day mortality.
The TOMAHAWK trial is supported by the Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK).
详细描述
After inclusion and exclusion criteria have been checked patients will be randomized:
Group 1: Immediate angiography Patients randomized to group 1 will be transported to the catheterization laboratory as soon as possible after hospital admission for evaluation of coronary anatomy.
Group 2: Delayed/selective angiography Upon hospital admission, patients assigned to group 2 will first be transported to the ICU for further evaluation and stratification of OHCA etiology. Further triage will depend on the results of clinical examination and objective testing and will be left to the individual physician according to clinical judgment. Depending on clinical circumstances, further management may comprise medical therapy, laboratory testing, imaging such as echocardiography and/or computed tomography, hemodynamic or neurological monitoring, the initiation of therapeutic hypothermia or other measures of intensive care. If a high likelihood of an acute coronary trigger for OHCA persists (i.e. inconclusive results from clinical evaluation with ongoing suspicion of an acute coronary event, etc.), the treating physician may proceed to coronary angiography after a delay of 24h after the onset of cardiac arrest.
Vital status will be assessed at 30 days, 6 and 12 months after randomization by direct questioning if the patient is still hospitalized or structured telephone interview. Clinical events will be verified by original source data. At 6 and 12 months, quality of life will be assessed by the the Euroqol 5D questionnaire.
The TOMAHAWK trial is supported by the Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK).
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
- 30 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented resuscitated OHCA of possible cardiac origin and return of spontaneous circulation
- •Age ≥30 years
- •Informed consent
排除标准
- •ST-segment elevation or new left bundle branch block
- •No return of spontaneous circulation upon hospital admission
- •Severe hemodynamic or electrical instability requiring immediate coronary angiography/intervention (delay clinically not acceptable)
- •Obvious extra-cardiac etiology such as traumatic brain injury, primary metabolic or electrolyte disorders, intoxication, overt hemorrhage, respiratory failure due to known lung disease, suffocation, drowning
- •In-hospital cardiac arrest
- •Known or likely pregnancy
- •Participation in another intervention study
研究组 & 干预措施
Immediate coronary angiography
Immediate coronary angiography in survivors of out-of-hospital cardiac arrest without ST-segment elevation
干预措施: Immediate coronary angiography (Other)
Delayed/selective coronary angiography
Initial intensive care evaluation to further stratify the etiology of out-of-hospital cardiac arrest with delayed/selective coronary angiography if indicated
干预措施: Delayed/selective coronary angiography (Other)
结局指标
主要结局
All-cause mortality
时间窗: 30 days
次要结局
未报告次要终点
研究者
Steffen Desch
Associate director
University Hospital Schleswig-Holstein
