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Out of Hospital Cardiac ArrestNCT04431661

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

An observational study of Out of Hospital Cardiac Arrest, run by Ceric Sàrl at 7 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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 . Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Out of Hospital Cardiac Arrest
What is being tested?
Optical Coherence Tomography, Coronary Angiography and Per cutaneous coronary intervention
How many people
28 participants
Where
7 sitesin 3 countries
Study dates
29 Jan 2021to 31 Jan 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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).

Who cannot join

  • 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).

Trial locations and contacts

7 sites in 3 countries.

7 sites in 3 countries

France5 sites

  • CHU Gabriel-Montpied

    Clermont-Ferrand, 63000

  • CHU Timone Adultes

    Marseille, 13385

  • Hôpital Lariboisière

    Paris, 75010

  • Hôpital Cochin

    Paris, 75014

  • CHU Toulouse Rangueil

    Toulouse, 31400

Other trials in France

Belgium1 site

  • UZ Leuven

    Leuven, 3000

Other trials in Belgium

Serbia1 site

  • Clinical Center of Serbia. School of medicine

    Belgrade, 11000

Other trials in Serbia

About this study

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

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.

Being tested
Optical Coherence Tomography, Coronary Angiography, Per cutaneous coronary intervention
Medical subject headings
Out-of-Hospital Cardiac Arrest

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Optical Coherence TomographyProcedure or surgery

    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 AngiographyProcedure or surgery

    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 interventionProcedure or surgery

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Intra operative, up to 12 months

Secondary outcomes (12)

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

    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.

    Measured: Intra operative, up to 12 months

  2. 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

    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.

    Measured: Intra operative, up to 12 months

  3. The percentage of unstable lesions (core lab OCT) intended to be left untreated by PCI after peri procedural (as assessed by investigators) angiography

    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.

    Measured: Intra operative, up to 12 months

  4. The percentage of stable lesions (core lab OCT) intended to be treated by PCI after peri procedural (as assessed by investigators) conventional angiography

    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.

    Measured: Intra operative, up to 12 months

  5. The percentage of misclassification for unstable lesion between peri procedural (as assessed by investigators) OCT and core lab OCT analysis.

    The unstable lesion as detected during the procedure by the investigator and compared with the corelab analysis.

    Measured: Intra operative, up to 12 months

  6. The duration of the procedure

    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).

    Measured: Intra operative, up to 12 months

  7. The irradiation during the procedure

    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.

    Measured: Intra operative, up to 12 months

  8. The volume of contrast dye injection

    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

    Measured: Intra operative, up to 12 months

  9. The rate of OCT-related complications

    The OCT related complications include coronary dissection, perforation, plaque embolization etc.

    Measured: Intra operative, up to 12 months

  10. The rate of Major Adverse Coronary and Cerebrovascular Events (MACCE).

    The MACCE evaluation will include all-cause mortality, myocardial infarction, stroke, ischemia driven target lesion revascularization.

    Measured: Day 1, Day 30 and Day 90

  11. The rate of all-cause mortality

    This includes all cause mortality rate

    Measured: Day 1, Day 30, Day 90 and Day 365

  12. The rate of stent thrombosis

    According to Academic Research Consortium-2 (ARC2) definition

    Measured: Day 1, Day 30 and Day 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2020
  2. Study start29 Jan 2021
  3. Primary completion31 Jan 2023
  4. Study completion31 Jan 2023

Why it stopped: Low patient recruitment rate and change of hopsital procedures for handling cardiac arrest patients during emergency

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04431661
Sponsor's protocol ID
The CAOCT Study
Status last verified
Mar 2023
First submitted
11 Jun 2020
Last updated
13 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • McDonnell SJ, Gates S, Perkins GD. Utstein recommendations for reporting out of hospital cardiac arrest (OHCA) registry studies-A review of the literature. Resuscitation. 2017;118:e103.

  • Miller LM, Gal A. Cardiovascular system and lymphatic vessels. Pathologic basis of veterinary disease. 2017:561.

  • Hepler MD, Schafer MF. Chapter 18 - Surgical Treatment of Lumbar Spinal Disorders. In: Benzon HT, Rathmell JP, Wu CL, Turk DC, Argoff CE, editors. Raj's Practical Management of Pain (Fourth Edition). Philadelphia: Mosby; 2008. p. 389-400.

  • Marso SP. 23 - Revascularization Approaches. In: de Lemos JA, Omland T, editors. Chronic Coronary Artery Disease: Elsevier; 2018. p. 337-54.

  • 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.

  • 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.

    PubMed 30928505

  • 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.

    PubMed 29891620

  • 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.

    PubMed 31035776

  • Lemkes JS, Janssens GN, van der Hoeven NW, Jewbali LSD, Dubois EA, Meuwissen M, Rijpstra TA, Bosker HA, Blans MJ, Bleeker GB, Baak R, Vlachojannis GJ, Eikemans BJW, van der Harst P, van der Horst ICC, Voskuil M, van der Heijden JJ, Beishuizen A, Stoel M, Camaro C, van der Hoeven H, Henriques JP, Vlaar APJ, Vink MA, van den Bogaard B, Heestermans TACM, de Ruijter W, Delnoij TSR, Crijns HJGM, Jessurun GAJ, Oemrawsingh PV, Gosselink MTM, Plomp K, Magro M, Elbers PWG, van de Ven PM, Oudemans-van Straaten HM, van Royen N. Coronary Angiography after Cardiac Arrest without ST-Segment Elevation. N Engl J Med. 2019 Apr 11;380(15):1397-1407. doi: 10.1056/NEJMoa1816897. Epub 2019 Mar 18.

    PubMed 30883057

  • 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.

    PubMed 24832635

  • O'Gara PT, Kushner FG, Ascheim DD, Casey DE Jr, Chung MK, de Lemos JA, Ettinger SM, Fang JC, Fesmire FM, Franklin BA, Granger CB, Krumholz HM, Linderbaum JA, Morrow DA, Newby LK, Ornato JP, Ou N, Radford MJ, Tamis-Holland JE, Tommaso CL, Tracy CM, Woo YJ, Zhao DX; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines; American College of Emergency Physicians; Society for Cardiovascular Angiography and Interventions. 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: executive summary: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines: developed in collaboration with the American College of Emergency Physicians and Society for Cardiovascular Angiography and Interventions. Catheter Cardiovasc Interv. 2013 Jul 1;82(1):E1-27. doi: 10.1002/ccd.24776. Epub 2013 Jan 8. No abstract available.

    PubMed 23299937

  • Patel N, Patel NJ, Macon CJ, Thakkar B, Desai M, Rengifo-Moreno P, Alfonso CE, Myerburg RJ, Bhatt DL, Cohen MG. Trends and Outcomes of Coronary Angiography and Percutaneous Coronary Intervention After Out-of-Hospital Cardiac Arrest Associated With Ventricular Fibrillation or Pulseless Ventricular Tachycardia. JAMA Cardiol. 2016 Nov 1;1(8):890-899. doi: 10.1001/jamacardio.2016.2860.

    PubMed 27627616

  • Roger VL, Weston SA, Killian JM, Pfeifer EA, Belau PG, Kottke TE, Frye RL, Bailey KR, Jacobsen SJ. Time trends in the prevalence of atherosclerosis: a population-based autopsy study. Am J Med. 2001 Mar;110(4):267-73. doi: 10.1016/s0002-9343(00)00709-9.

    PubMed 11239844

  • Zahger D. Immediate coronary angiography in survivors of out-of-hospital cardiac arrest. N Engl J Med. 1997 Oct 30;337(18):1321-2. doi: 10.1056/NEJM199710303371816. No abstract available.

    PubMed 9380089

  • Spaulding CM, Joly LM, Rosenberg A, Monchi M, Weber SN, Dhainaut JF, Carli P. Immediate coronary angiography in survivors of out-of-hospital cardiac arrest. N Engl J Med. 1997 Jun 5;336(23):1629-33. doi: 10.1056/NEJM199706053362302.

    PubMed 9171064

Questions about this trial

What is this clinical trial studying?

An observational study of Out of Hospital Cardiac Arrest, run by Ceric Sàrl at 7 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in France, Belgium, Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Low patient recruitment rate and change of hopsital procedures for handling cardiac arrest patients during emergency). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04431661, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2023.

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