Direct or Subacute Coronary Angiography in Out-of-hospital Cardiac Arrest (DISCO)

Uppsala University

Status: Enrolling

Conditions: Out-of-Hospital Cardiac Arrest

Treatments: Procedure: Immediate coronary angiography

Study type: Interventional

Funder types: Other

Identifiers

NCT02309151

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Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,006 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,006 participants in 2 patient groups

Immediate coronary angiography

Experimental group

Description:

Immediate coronary angiography for out of hospital cardiac arrest patients with no signs of ST elevation on their first ECG after ROSC

Treatment:

Procedure: Immediate coronary angiography

Not immediate coronary angiography

No Intervention group

Description:

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.