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

NCT04431661 | Terminated

• 1 other identifier: The CAOCT Study
• Study Type: observational
• Target: 28
• Locations: 3 countries
• Sites: 7

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.

Conditions

Out of Hospital Cardiac Arrest

Outcome Measures

Primary Outcomes (1)

• Rate of misclassification of at least one unstable coronary artery lesion per patient, between core lab angiography and core lab OCT assessments.

  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 Outcomes (12)

• The misclassification rate per coronary artery segment analysis, on angiography versus OCT (both techniques peri procedural as assessed by investigators)

  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

  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

  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

  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.

  Intra operative, up to 12 months

Interventions

Optical Coherence Tomography PROCEDURE

OCT (DragonFly, Abbott Vascular) will be performed after angiography. OCT images will be acquired using the 6F guide catheter compatible DragonFly System (Abbott Vascular, Santa Clara, USA). The catheter will be introduced into the first coronary artery via a standard 0.014-inch angioplasty wire, after prior injection of an intracoronary bolus of nitro-glycerine (according to the hemodynamic conditions of the patient). To remove all blood adequately from the imaging site, nonocclusive flushing will be performed using continuously inject via an automated power injector, and the OCT catheter will be pulled back at a speed of 18 mm/second to guarantee sufficient time to acquire images of a 54 mm long segment (frame density: 10 frames/mm).

Coronary Angiography PROCEDURE

The coronary angiography will be performed according to the strategies described in the consensus statement from the European Association for Percutaneous Cardiovascular Interventions (EAPCI)/Stent for Life (SFL) groups.Transradial or transfemoral 6F/7F approaches are recommended. The choice of diagnostic catheters, guiding catheters, guidewires, pre-dilatation, atherectomy devices, and post dilatation is let to the investigator's discretion.

Per cutaneous coronary intervention PROCEDURE

Based on coronary angiography and OCT analyses by the investigators, PCI will be performed, preferentially for the identified culprit lesion(s) only. The guiding catheters, guidewires, pre-dilatation, atherectomy devices, and post dilatation are left to physician discretion. The use of semi- or non-compliant balloons number and diameter of drug eluting stent(s) will also be left to the physician discretion, but post dilation will be strongly recommended in case of PCI. OCT can eventually be performed after stent implantation to guide, post dilation strategy.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ceric Sàrl: lead
• Abbott: collaborator

Study Sites (7)

UZ Leuven

Leuven, 3000, Belgium

Location

CHU Gabriel-Montpied

Clermont-Ferrand, 63000, France

Location

CHU Timone Adultes

Marseille, 13385, France

Location

Hôpital Lariboisière

Paris, 75010, France

Location

Hôpital Cochin

Paris, 75014, France

Location

CHU Toulouse Rangueil

Toulouse, 31400, France

Location

Clinical Center of Serbia. School of medicine

Belgrade, 11000, Serbia

Location

Related Publications (21)

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• Ibrahim K, editor Increased rate of stentthrombosis due to clopidogrel resistance in patients in therapeutic hypothermia after sudden cardiac death. European Heart Journal; 2011: OXFORD UNIV PRESS GREAT CLARENDON ST, OXFORD OX2 6DP, ENGLAND.

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• Degrell P, Picard F, Combaret N, Mogi S, Motreff P, Cariou A, Varenne O. Coronary atherothrombosis in cardiac arrest survivors without ST-segment elevation on ECG. Resuscitation. 2019 Jun;139:189-191. doi: 10.1016/j.resuscitation.2019.01.046. Epub 2019 Mar 27. No abstract available.

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• Garcia-Garcia HM, McFadden EP, Farb A, Mehran R, Stone GW, Spertus J, Onuma Y, Morel MA, van Es GA, Zuckerman B, Fearon WF, Taggart D, Kappetein AP, Krucoff MW, Vranckx P, Windecker S, Cutlip D, Serruys PW; Academic Research Consortium. Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document. Circulation. 2018 Jun 12;137(24):2635-2650. doi: 10.1161/CIRCULATIONAHA.117.029289.

  PMID: 29891620 RESULT

• Heitner JF, Senthilkumar A, Harrison JK, Klem I, Sketch MH Jr, Ivanov A, Hamo C, Van Assche L, White J, Washam J, Patel MR, Bekkers SCAM, Smulders MW, Sacchi TJ, Kim RJ. Identifying the Infarct-Related Artery in Patients With Non-ST-Segment-Elevation Myocardial Infarction. Circ Cardiovasc Interv. 2019 May;12(5):e007305. doi: 10.1161/CIRCINTERVENTIONS.118.007305.

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  PMID: 30883057 RESULT

• Noc M, Fajadet J, Lassen JF, Kala P, MacCarthy P, Olivecrona GK, Windecker S, Spaulding C; European Association for Percutaneous Cardiovascular Interventions (EAPCI); Stent for Life (SFL) Group. Invasive coronary treatment strategies for out-of-hospital cardiac arrest: a consensus statement from the European association for percutaneous cardiovascular interventions (EAPCI)/stent for life (SFL) groups. EuroIntervention. 2014 May;10(1):31-7. doi: 10.4244/EIJV10I1A7.

  PMID: 24832635 RESULT

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MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Officials

• Olivier Varenne, MD, PHD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2020
• First Posted: June 16, 2020
• Study Start: January 29, 2021
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: March 13, 2023

Record last verified: 2023-03

Locations

BE (1); FR (5); SE (1)