CAOCT: Intra CoronAry Optical Computerized Tomography in out-of Hospital Cardiac Arrest Patients

  • STATUS
    Recruiting
  • End date
    Jun 11, 2024
  • participants needed
    131
  • sponsor
    Ceric Sàrl
Updated on 11 June 2021

Summary

Out-of-hospital cardiac arrest (OHCA) is a leading cause of sudden death in Europe and the United States. Mortality is currently close to 40% among those patients who had been successfully resuscitated after OHCA associated with ventricular fibrillation or pulseless ventricular tachycardia . Coronary artery disease is observed in up to 70% of patients with OHCA and immediate coronary angiography . Current European and American guidelines recommend immediate coronary angiography with primary angioplasty in OHCA patients with ST-segment elevation on ECG after successful resuscitation . Furthermore, the identification of the culprit lesion by coronary angiography among patients with an acute coronary syndrome (ACS) and no OHCA is challenging. In a recent cardiac magnetic resonance study, Heitner et al. found that in almost half of the patients with non-ST segment elevation ACS, the culprit lesion was not properly detected or identified by coronary angiography. In the Coronary Angiography after cardiac arrest (COACT) trial, a randomized controlled trial comparing immediate versus delayed coronary angiography after OHCA in patients without ST segment elevation on ECG, some degree of coronary artery disease was found in 64.5% of the patients in the immediate angiography group and an unstable coronary lesion was identified in only 13.6% of the patients. However, in survivors of OHCA without ST segment elevation on ECG, the use of intra coronary optical computerized tomography (OCT) led to identification of plaque rupture (27%), plaque erosion (36%) and coronary thrombosis (59%) undetected on angiography. There is hence a clear need to improve causality diagnosis among patients resuscitated after OHCA and without ST segment elevation on ECG, and, in the case of coronary artery disease detection, to better identify the culprit vessel/lesion ultimately leading to a targeted treatment. These are the reasons why we have designed a prospective, multi-centre, single cohort, diagnostic accuracy study: to better explore the incidence of a true ACS among OHCA survivors and to evaluate the accuracy of angiography to detect the culprit lesion when compared to OCT.

Details
Condition Out-of-Hospital Cardiac Arrest, out-of-hospital cardiac arrests, out of hospital cardiac arrest
Treatment Optical Coherence Tomography, Coronary Angiography, Per cutaneous coronary intervention
Clinical Study IdentifierNCT04431661
SponsorCeric Sàrl
Last Modified on11 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Subjects of age 18 years and 85 years
The delay between OHCA and basic life support (no flow period) is 5 minutes
First recorded ECG exhibits a shockable rhythm (ventricular tachycardia/ventricular fibrillation)

Exclusion Criteria

The patient is still receiving cardiac massage at the time of admission in the cath-lab
There is an obvious extra cardiac cause to the cardiac arrest (suicide, drowning, hanging, trauma etc.)
The patient has prior coronary artery bypass grafting
The patient has incessant ventricular tachycardia/fibrillation
The patient has at least one acute or chronic coronary occlusion of an epicardial coronary artery 2.0mm of diameter on conventional angiography, The coronary artery anatomy does not allow realization of three vessels OCT according to the interventional cardiologist (severe tortuosity, severe calcifications etc.)
The patient is in cardiogenic shock or with a left ventricular assistance device
The post ROSC ECG (12 leads) exhibits ST segment elevation (defined as a 1mm ST segment elevation in two or more contiguous standard leads or as a 2mm ST segment elevation in two or more precordial leads)
The post ROSC ECG (12 leads) exhibits new left bundle block branch (LBBB)
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