Cardiac Catheterization in Cardiac Arrest
Role of Early Cardiac Catheterization in Cardiac Arrest
研究概览
详细说明
A pilot multicenter RCT.
The objectives of the study are:
To assess whether early (within 12 hours) cardiac catheterization is associated with improved survival, neurologic and cardiovascular outcomes in OHCA patients.
Patients will be randomized 1:1 to early cardiac catheterization, performed as early as possible, within 12h post return of spontaneous circulation (ROSC) following OHCA, or to standard practice, which may include medical management without cardiac catheterization or late cardiac catheterization after completion of therapeutic hypothermia. Percutaneous coronary intervention (PCI) is recommended for culprit lesions found on diagnostic angiography. All patients will undergo therapeutic hypothermia started as soon as possible with target temperature below 36°C according to local practice. Other medical management will be according to standard of care
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Ontario
-
London、Ontario、加拿大、N6A5A5
- London Health Sciences Centre
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Glasgow Coma Scale score <8 on hospital admission following OHCA of presumed cardiac cause.
- Initial rhythm ventricular tachycardia (VT) / ventricular fibrillation (VF), who achieved ROSC sustained for >20 consecutive minutes
Exclusion Criteria:
- ST-elevation on any of the ECGs post resuscitation
- Hypothermia <30°C
- Interval from ROSC to screening of >12h
- Suspected or known acute intracranial hemorrhage or stroke
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Early cardiac catheterization
Cardiac catheterization performed as early as possible, within 12h post ROSC following OHCA, with possible PCI during mild therapeutic hypothermia or apyrexia
|
Cardiac catheterization / coronary angiography is a diagnostic procedure used to define the coronary anatomy and presence of obstructive coronary lesions or culprit lesions.
According to the findings, it may lead to percutaneous coronary intervention (PCI) using stents
其他名称：
|
|
无干预：Medical arm
Initial therapy does not include cardiac catheterization.
Cardiac catheterization with possible PCI is allowed after completion of mild therapeutic hypothermia or apyrexia for >24h post ROSC.
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Composite of death and poor neurologic outcomes ( Cerebral Performance Category [CPC] score 3-5).
大体时间：30 days
|
30 days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Death
大体时间：30 day
|
30 day
|
|
|
CPC score
大体时间：up to 30 days
|
up to 30 days
|
|
|
Acute kidney injury- creatinine levels
大体时间：48 hours
|
Number of participants with increase in serum creatinine of ≥44.2 μmol/L, or a 25% relative rise in creatinine, within 48 h after contrast exposure42
|
48 hours
|
|
Myocardial infarction - according to cardiac troponin levels
大体时间：30 days
|
Number of participants with myocardial infarction post percutaneous coronary interventions, in accordance with the universal definition of myocardial infarction.
|
30 days
|
|
Stent thrombosis by pathology or angiography
大体时间：30 days
|
Number of participants with definite stent thrombosis confirmed by angiography or pathology according to the Academic research consortium criteria
|
30 days
|
|
Bleeding - according to Hb levels
大体时间：30 days
|
Number of participant with overt bleeding according to Academic Research Consortium criteria
|
30 days
|
|
Composite of death and poor neurologic outcome
大体时间：1 year
|
1 year
|
|
|
Stroke - imaging or pathology
大体时间：30 days
|
New stroke following hypothermia confirmed by imaging (computer tomography or magnetic resonance imaging)
|
30 days
|
|
Heart failure (NYHA 3-4)
大体时间：30 days
|
30 days
|
|
|
Estimated cost per patient according to length of stay and procedures performed
大体时间：30 days
|
30 days
|
合作者和调查者
调查人员
- 首席研究员：Shahar Lavi, MD、London Health Sciences Centre
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.