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

March 10, 2023 updated by: Ceric Sàrl

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

28

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • UZ Leuven
  • France
      • Clermont-Ferrand, France, 63000
        • CHU Gabriel-Montpied
      • Marseille, France, 13385
        • CHU Timone Adultes
      • Paris, France, 75010
        • Hopital Lariboisiere
      • Paris, France, 75014
        • Hopital Cochin
      • Toulouse, France, 31400
        • CHU TOULOUSE Rangueil
  • Serbia
      • Belgrade, Serbia, 11000
        • Clinical Center of Serbia. School of medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of misclassification of at least one unstable coronary artery lesion per patient, between core lab angiography and core lab OCT assessments.
Time Frame: Intra operative, up to 12 months

The core lab OCT analysis is considered as the gold standard for unstable coronary lesion detection.

Detection of unstable coronary lesion by OCT includes atherosclerosis plaque rupture/erosion and thrombosis, calcified noduli with apposed thrombus, and spontaneous coronary dissection.

Angiographically, unstable coronary lesions are defined as coronary lesions with at least >50% stenosis and the presence of characteristics of plaque disruption, including irregularity, dissection, haziness, or thrombus.

A misclassification is either an unstable lesion detected by core lab OCT and misdiagnosed or undiagnosed on core lab angiography, or an unstable lesion as defined on core lab angiography but without plaque rupture/erosion and thrombosis, calcified noduli with apposed thrombus, and spontaneous coronary dissection on core lab OCT.
Intra operative, up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The misclassification rate per coronary artery segment analysis, on angiography versus OCT (both techniques peri procedural as assessed by investigators)
Time Frame: Intra operative, up to 12 months
All analysable coronary segments according to the American Heart Association (AHA) classification (8) will be included in the final analysis. All paired (peri procedural as assessed by investigators angio and OCT) analysed segments will be included in the analysis.
Intra operative, up to 12 months
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
Time Frame: Intra operative, up to 12 months
This endpoint represents a comparison between the management of the culprit lesion identified by the investigator after coronary angiography (and strictly captured in the electronic Case Report Form (eCRF) before OCT) and management of the culprit lesion as identified after OCT. Change in interventional management will include patients in whom an initially planned PCI was hold off after OCT and, vice versa, those declined a PCI in whom a PCI was finally decided after OCT. A patient for whom angiography and OCT-based diagnosis would lead to PCI of an additional but distinct coronary segment within the same vessel will be considered as a change in PCI plan.
Intra operative, up to 12 months
The percentage of unstable lesions (core lab OCT) intended to be left untreated by PCI after peri procedural (as assessed by investigators) angiography
Time Frame: Intra operative, up to 12 months
The percentage of unstable lesions as defined by the core lab OCT core lab that were not defined as potential culprit lesion by the investigators after conventional angiography. This will reflect the incidence of undiagnosed and untreated coronary culprit coronary lesion after OHCA.
Intra operative, up to 12 months
The percentage of stable lesions (core lab OCT) intended to be treated by PCI after peri procedural (as assessed by investigators) conventional angiography
Time Frame: Intra operative, up to 12 months
A stable lesion will be defined as a coronary stenosis ≥20% without any features of instability (no plaque rupture or erosion, no thrombosis) on core-lab OCT.
Intra operative, up to 12 months
The percentage of misclassification for unstable lesion between peri procedural (as assessed by investigators) OCT and core lab OCT analysis.
Time Frame: Intra operative, up to 12 months
The unstable lesion as detected during the procedure by the investigator and compared with the corelab analysis.
Intra operative, up to 12 months
The duration of the procedure
Time Frame: Intra operative, up to 12 months
Duration on the procedure will include timing from arterial sheath insertion to final run of angiography (angio), to final run of OCT (intracoronary imaging), and from the end of the angiography or intra coronary imaging to the end of the PCI procedure when applicable (Usually between set puncture to introducer removal).
Intra operative, up to 12 months
The irradiation during the procedure
Time Frame: Intra operative, up to 12 months
Patient irradiation will be determined after conventional angiography (angio), after OCT procedure (intracoronary imaging), and after PCI when applicable (angioplasty). Total procedural irradiation will also be calculated as the cumulative irradiation received during angio, intracoronary imaging and PCI if applicable.
Intra operative, up to 12 months
The volume of contrast dye injection
Time Frame: Intra operative, up to 12 months
The volume of contrast dye injection will be determined after conventional angiography (angio), after OCT procedure (intracoronary imaging), and after PCI when applicable (angioplasty). Total volume of contrast dye injection will also be calculated as the cumulative volume injected during angio, intracoronary imaging and PCI when applicable
Intra operative, up to 12 months
The rate of OCT-related complications
Time Frame: Intra operative, up to 12 months
The OCT related complications include coronary dissection, perforation, plaque embolization etc.
Intra operative, up to 12 months
The rate of Major Adverse Coronary and Cerebrovascular Events (MACCE).
Time Frame: Day 1, Day 30 and Day 90
The MACCE evaluation will include all-cause mortality, myocardial infarction, stroke, ischemia driven target lesion revascularization.
Day 1, Day 30 and Day 90
The rate of all-cause mortality
Time Frame: Day 1, Day 30, Day 90 and Day 365
This includes all cause mortality rate
Day 1, Day 30, Day 90 and Day 365
The rate of stent thrombosis
Time Frame: Day 1, Day 30 and Day 90
According to Academic Research Consortium-2 (ARC2) definition
Day 1, Day 30 and Day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ceric Sàrl

Collaborators

Abbott

Investigators

  • Principal Investigator: Olivier Varenne, MD, PHD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 29, 2021

Primary Completion (Actual)

January 31, 2023

Study Completion (Actual)

January 31, 2023

Study Registration Dates

First Submitted

June 11, 2020

First Submitted That Met QC Criteria

June 11, 2020

First Posted (Actual)

June 16, 2020

Study Record Updates

Last Update Posted (Actual)

March 13, 2023

Last Update Submitted That Met QC Criteria

March 10, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • The CAOCT Study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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