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临床试验/NCT02309151
NCT02309151已完成不适用

Direct or Subacute Coronary Angiography in Out-of-hospital Cardiac Arrest - a Prospective, Randomized Study

Uppsala University32 个研究点 分布在 3 个国家目标入组 1,003 人开始时间: 2014年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,003
试验地点
32
主要终点
30 day survival

研究概览

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

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

Experimental

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 (Procedure)

Not immediate coronary angiography

No Intervention

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))

研究者

发起方
Uppsala University
申办方类型
Other
责任方
Sponsor

研究点 (32)

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