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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
Immediate coronary angiography for out of hospital cardiac arrest patients with no signs of ST elevation on their first ECG after ROSC
Aalborg University hospital
Aalborg, Denmark
Aarhus University Hospital
Aarhus, Denmark
30 day survival
Follow up will be performed at 30 days, telephone call or visit.
Time frame: 30 days
Survival with good neurological function
30-day survival and a follow up of health status, functional outcome associated to cerebral performance and general functional outcome/activities of daily living
Time frame: 30 days
Survival at discharge from ICU (individual for each subject) and at 6-months
Recorded in the e-CRF (electronic Case Report Form)
Time frame: At discharge from ICU, an expected average of 3-30 days and at 6-months
Survival with good neurological function at discharge from ICU and 6-months
Survival with good neurological function at discharge and at 6-months. Assessing functional outcome associated to cerebral performance and general functional outcome/activities of daily living and also global functional outcome, independent living and social reintegration at 6-months
Time frame: At discharge from ICU, an expected average of 3-30 days and at 6-months
Cardiac function
Measured with echocardiography
Time frame: 72 hours and at 6 months
Follow up of neurological function at 6-months
A 6 month follow up of neurological function will be assessed by validated screening battery in OHCA (Out of Hospital Cardiac Arrest) patients in general functional outcome, activities of daily living, cognitive functioning, attention, anxiety and depression, fatigue, cardiac disease specific health and care giver burden.
Time frame: Measured at 6 months
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1,003
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
...and 11 more locations
Hemodynamic parameters (urine output, highest lactate and vasopressor/inotropic support)
Parameters measured daily during ICU care
Time frame: During ICU care (maximum of 7 days)
ECG findings compared to findings at coronary angiography
Primary ECG, performed in the pre-hospital setting or at the emergency department, will be compared with findings at coronary angiography intervention (performed immediately or later during hospital stay depending on randomisation)
Time frame: During hospital stay up to a maximum of 6-months