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Direct or Subacute Coronary Angiography in Out-of-hospital Cardiac Arrest - a Prospective, Randomized Study
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Aalborg University hospital
Aalborg, Denmark
Aarhus University Hospital
Aarhus, Denmark
Odense University hospital
Odense, Denmark
Amsterdam UMC
Amsterdam, Netherlands
Albert Schweitzer Hospital
Dordrecht, Netherlands
Catharina Ziekenhuis
Eindhoven, Netherlands
Treant Hospital
Emmen, Netherlands
Zuyderland Hospital
Heerlen, Netherlands
Antonius Hospital
Nieuwegein, Netherlands
Radboud University Medical Center
Nijmegen, Netherlands
Start Date
December 1, 2014
Primary Completion Date
June 1, 2024
Completion Date
December 1, 2024
Last Updated
June 18, 2024
1,006
ESTIMATED participants
Immediate coronary angiography
PROCEDURE
Lead Sponsor
Uppsala University
NCT07438938
NCT06939335
Data Source & Attribution
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