Direct or Subacute Coronary Angiography in Patients With Out of Hospital Cardiac Arrest Without Coma. A Prospective Randomized Study.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 212
- 试验地点
- 14
- 主要终点
- Major Adverse Cardiovascular Events
研究概览
简要总结
In patients with Out-of-Hospital Cardiac arrest who achieves Return Of Spontaneous Circulation (ROSC) The investigators want to evaluate whether there is a benefit from acute Angiography compared to subacute (12-24 hours) Angiography
详细描述
Background: The majority of patients with out-of-hospital cardiac arrest (OHCA) have ischemic heart disease (IHD). If signs of ST-elevation myocardial infarction (STEMI) acute coronary angiography (CAG) and primary percutaneous coronary intervention (PPCI) is recommended. In most cases, patients with OHCA who does not achieve Return Of Spontaneous Circulation (ROSC) are also triaged directly to a tertiary center with the possibility to establish mechanical circulatory support, e.g. Extracorporeal Cardiopulmonary Resuscitation (eCPR) (Figure 1). For the remaining group of patients with OHCA who achieves ROSC and have no signs of STEMI it is unsettled whether there is a benefit of acute CAG.
A large international study (Direct or Subacute COronary angiography in out-of-hospital cardiac arrest - DISCO) from Uppsala, Sweden, will study the role of acute CAG in 1006 patients with OHCA who are comatose after achieving ROSC (2). In the Swedish study they only include comatose patients, and randomize patients to either acute CAG or CAG after 3 days.
Three of four Danish tertiary centers have decided to join the Swedish DISCO-study (From now on named DISCO-MAIN).
However, many OHCA patients are not comatose, and without signs of STEMI, thus not eligible for DISCO-MAIN. The investigators also want to investigate the role of acute CAG in these patients, which is the purpose of the current study, named DISCO-no-COMA (Direct or subacute coronary angiography in patients with out-of-hospital-cardiac arrest who are not comatose). This study will include patients in parallel with the DISCO-MAIN-study. This means that all patients with OHCA who receive ROSC and do not fulfill the criteria for acute CAG (STEMI) can be randomized in either DISCO-MAIN (if comatose) or DISCO-no-COMA (if not comatose).
This means that a patient with OHCA without obvious non-cardiac cause, should be triaged as follows (See figure 1):
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
- 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
- 是
入选标准
- •Witnessed Cardiac Arrest
- •CAG possible within 120 minutes
- •Glasgow coma scale >8
排除标准
- •Age < 18 years
- •Obvious non-cardiac cause for the arrest
- •Terminal illness
研究组 & 干预措施
Acute CAG
The patient is triaged directly to the catheterization laboratory for acute evaluation including ECHO, acute CAG and PCI if indicated according to guidelines.
干预措施: Acute CAG (Procedure)
Subacute CAG
The patient is triaged to the coronary care unit (CCU) for rhythm surveillance, and additional diagnostics, and in case there is found indication for CAG, it is planned for the coming day in daytime (12-24 hours after cardiac arrest). Revascularization is performed if indicated according to guidelines.
结局指标
主要结局
Major Adverse Cardiovascular Events
时间窗: 30-day
Mortality, cardiogenic shock or recurrent cardiac arrest
次要结局
- Glasgow Outcome Scale Extended(6-month)
- Montreal Cognitive Assessment(6-month)
- AMPS(6-month)
- Treatment with ICD(1-year)
- Mortality(30-day and 1-year and 5-year)
- modified Ranking Scale score(30-day and 6-month)
- ADL-1 score(6-month)
- Shock from ICD(After randomization and within 30-day and 5-year)
- Increase in creatinin(30-day)
- Renal resistive index(1-day and 3-day)
- Cardiogenic shock(30-day and 1-year)
- Dialysis(30-day)
- Cross-over rate(During admission, 30-day)
- Vascular surgery(30-day)
- Cerebral Performance Category score(30-day and 6-month)
- Recurrent cardiac arrest(30-day and 5-year)
- Revascularization(30-day and 1-year)
- Admission time(30-day)
- MWA index(1-day and 3-day)
- Renal and liver flow(1-day, 3-day, 6-month)
- EQ-5D-5L score(30-day and 6-month)
- AMI(1-year)
- Readmission with CHF(1-year)
- Bleeding(30-day)
研究者
Christian Juhl Terkelsen
Principal investigator
Aarhus University Hospital Skejby