Immediate coronary angiography
ProcedureImmediate coronary angiography for out of hospital cardiac arrest patients with no signs of ST elevation on their first ECG after ROSC
NCT Number: NCT02309151
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Aalborg University hospital, Aalborg, Denmark
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Immediate coronary angiography for out of hospital cardiac arrest patients with no signs of ST elevation on their first ECG after ROSC
Time frame: 30 days
Follow up will be performed at 30 days, telephone call or visit.
Time frame: 30 days
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: At discharge from ICU, an expected average of 3-30 days 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 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: 72 hours and at 6 months
Measured with echocardiography
Time frame: Measured 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: During ICU care (maximum of 7 days)
Parameters measured daily during ICU care
Time frame: During hospital stay up to a maximum of 6-months
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)
Uppsala University
Other
Direct or Subacute Coronary Angiography in Out-of-hospital Cardiac Arrest - a Prospective, Randomized Study
Acronym: DISCO
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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