A Pilot Randomized Clinical Trial of Early Coronary Angiography Versus No Early Coronary Angiography for Post-Cardiac Arrest Patients Without ECG ST Segment Elevation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 99
- 试验地点
- 6
- 主要终点
- Safety and Efficacy of early coronary angiography in the out-of-hospital cardiac arrest (OHCA) patient population.
研究概览
简要总结
This study is a pilot, multi-centered, randomized, clinical trial to evaluate the safety and efficacy of performing early Coronary Angiography (CAG) versus no early CAG in post-cardiac arrest patients without ST segment elevation. Safety will be assessed by evaluating the association of major adverse events (re-arrest, bleeding, pulmonary edema, hypotension, acute renal insufficiency, and pneumonia) with early coronary angiogram. Efficacy will be assessed by a composite endpoint of improved left ventricular regional and global function (both regional wall motion analysis and left ventricular ejection fraction) as measured by echocardiography prior to hospital discharge and favourable neurological function (Cerebral Performance Categories 1 or 2) at discharge.
详细描述
Cardiac arrest is a major public health issue. Arizona has been a leader in improving long-term survival by introducing new and innovative resuscitation approaches including "Chest Compression-Only CPR" and "Cardiocerebral Resuscitation". Post-resuscitation care is the next great opportunity for further improvements. Early coronary angiography (CAG) combined with therapeutic hypothermia has become the recommended standard of care for post-cardiac arrest patients manifesting ST segment elevation on their electrocardiogram (ECG). However, the majority of cardiac arrest victims do not have ST segment elevation. There is clinical equipoise as to whether these patients will benefit from early CAG.
Subjects who are qualified for the study will be randomized 1:1 to one of two groups.
° Intervention Group-Early coronary angiography (door-to-angiography) within 120 minutes of admission to Emergency Department.
or
° Control Group-No early coronary angiography (within the first six hours from admission)
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All successfully resuscitated out-of-hospital cardiac arrest patients with a suspected cardiac etiology for their non-traumatic arrest
- •Age greater than 18 years
- •The post resuscitation ECG shows no evidence of ST segment elevation
排除标准
- •Non-resuscitated (no sustained pulse and BP)
- •Presence ST segment elevation or new left bundle branch block present on the post-resuscitation ECG
- •Suspected non-cardiac etiology for their arrest such as respiratory failure, asphyxia, pulmonary embolus, shock, trauma, drug overdose, or CNS bleed as likely cause of the cardiac arrest
- •Known "Do Not Resuscitate" status
- •Minors (<18 years old)
- •Significant bleeding or blunt trauma
- •Known or confirmed pregnancy test by urinalysis
- •Patients who are known to have received any other investigational therapies within the 30 days prior to enrollment or during study duration will be excluded unless these studies have been reviewed and approved by the Study Steering Committee.
- •Known "opt out" choice; wearing Opt-out band for any EFIC approved study or on an "Opt-out" list
研究组 & 干预措施
Interventional
Early Angiography with purpose of coronary revascularization within 120 minutes of admission to ED, post out-of-hospital cardiac arrest, suspicious for cardiac etiology and no ST segment elevation on ECG
干预措施: Early Angiography (Procedure)
Control Group
Standard of care treatment including therapeutic hypothermia in subjects post resuscitation, out-of-hospital cardiac arrest, suspicious for cardiac etiology and no ST segment elevation on ECG.
结局指标
主要结局
Safety and Efficacy of early coronary angiography in the out-of-hospital cardiac arrest (OHCA) patient population.
时间窗: 180 days
Safety will be assessed by evaluating any association of major adverse events (re-arrest, bleeding, pulmonary edema, hypotension, acute renal insufficiency, and pneumonia) with early coronary angiography.
次要结局
- Survival from hospital at: 30 days post discharge and 180 days post discharge(30 days and 180 days)
- Cognitive functional status(180 days)
- Neurocognitive Testing(180 days)