Clinical trial NCT04431661: CAOCT: Intra CoronAry Optical Computerized Tomography in out-of Hospital Cardiac Arrest Patients
Official title: CAOCT Study is a Prospective, Multi-centre, Single Cohort, Diagnostic Accuracy Study, Planned to Include 131 Patients in About 3 European Countries After Successful Return of Spontaneous Circulation After Out of Hospital Cardiac Arrest
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Out of Hospital Cardiac Arrest
Lead sponsor: Ceric Sàrl
Sponsor class: INDUSTRY
Collaborators: name: Abbott
First posted: 2020-06-16
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All OHCA patients with no obvious non-cardiovascular reason managed by a pre-hospital emergency system will be screened for inclusion in the study

Brief 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Rate of misclassification of at least one unstable coronary artery lesion per patient, between core lab angiography and core lab OCT assessments.
timeFrame: Intra operative, up to 12 months
Secondary outcomes:
measure: The misclassification rate per coronary artery segment analysis, on angiography versus OCT (both techniques peri procedural as assessed by investigators)
timeFrame: Intra operative, up to 12 months
measure: The percentage of patients for whom peri procedural OCT findings change their management (including revascularization strategy) when compared to the initial therapeutic strategy decided upon after investigator-assessed on-line angiography
timeFrame: Intra operative, up to 12 months
measure: The percentage of unstable lesions (core lab OCT) intended to be left untreated by PCI after peri procedural (as assessed by investigators) angiography
timeFrame: Intra operative, up to 12 months
measure: The percentage of stable lesions (core lab OCT) intended to be treated by PCI after peri procedural (as assessed by investigators) conventional angiography
timeFrame: Intra operative, up to 12 months
measure: The percentage of misclassification for unstable lesion between peri procedural (as assessed by investigators) OCT and core lab OCT analysis.
timeFrame: Intra operative, up to 12 months
measure: The duration of the procedure
timeFrame: Intra operative, up to 12 months
measure: The irradiation during the procedure
timeFrame: Intra operative, up to 12 months
measure: The volume of contrast dye injection
timeFrame: Intra operative, up to 12 months
measure: The rate of OCT-related complications
timeFrame: Intra operative, up to 12 months
measure: The rate of Major Adverse Coronary and Cerebrovascular Events (MACCE).
timeFrame: Day 1, Day 30 and Day 90
measure: The rate of all-cause mortality
timeFrame: Day 1, Day 30, Day 90 and Day 365
measure: The rate of stent thrombosis
timeFrame: Day 1, Day 30 and Day 90
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
city: Clermont-Ferrand
country: France
facility: CHU Gabriel-Montpied
city: Marseille
country: France
facility: CHU Timone Adultes
city: Paris
country: France
facility: Hôpital Lariboisière
city: Paris
country: France
facility: Hôpital Cochin
city: Toulouse
country: France
facility: CHU Toulouse Rangueil
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia. School of medicine
Study officials:
name: Olivier Varenne, MD, PHD
role: PRINCIPAL_INVESTIGATOR
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