Performance of Coronary CT Angiography to Rule Out Coronary Artery Disease After Out-of-hospital Cardiac Arrest (PERFECCT)

March 5, 2024 updated by: CHU de Reims
Out-of-hospital cardiac arrest (OHCA) has multiple etiologies. In the absence of ST-elevation myocardial infarction, percutaneous coronary intervention (PCI) is delayed. This study aims to determine the diagnostic accuracy of Coronary Calcium Score (CCS) and Coronary CT Angiogram (CCTA) to rule out a coronary artery disease (CAD) in the first days after an OHCA.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Each year, 50.000 out-of-hospital cardiac arrest (OHCA) occur in France. Acute myocardial infarction (AMI) is one of the most frequent etiology of OHCA. When a cardiac arrest is due to a ST-elevation myocardial infarction (STEMI), a percutaneous coronary intervention (PCI) is realized in emergency. However, without ST-elevation, PCI timing is unclear. 2020 European Society Recommandations suggest that PCI should not be realized in emergency, based on Lemkes and al. clinical trial. But there is scarce evidence about the exact timing to realize PCI. Electrocardiogram, troponin level, and echocardiography are unprecise to rule-out an ischemic etiology of cardiac arrest.

A brain CT-scan and a CT-pulmonary angiogram are recommended in first place, to identify the etiology of the cardiac arrest if there is no ST-elevation nor obvious causes. Nevertheless, in the absence of scanographic abnormality, a differed coronary angiogram should be realized.

We suggest that coronary CT angiogram (CCTA) and coronary calcium score (CCS) are feasible in the first days of hospitalization, and could rule-out a coronary artery disease (CAD). The aim of the study is to avoid an invasive coronary exploration, and to have a quick answer about anti-thrombotic treatments management.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria :

  • Patients hospitalized in intensive care unit after a resuscitated out-of-hospital cardiac arrest
  • No obvious cause for sudden death on anamnestic information, CT brain and CT pulmonary angiogram.
  • Absence of ST elevation myocardial infarction

Non-inclusion criteria :

  • In-hospital cardiac arrest
  • Refractory cardiac arrest
  • Indication of immediate coronary angiography
  • ST-elevation myocardial infarction or unknown left bundle branch block
  • Dynamic or presumably new contiguous ST/T-segment changes
  • Cardiogenic shock
  • Life-threatening arrhythmias
  • Coronary artery bypass graft
  • Pregnancy
  • Multiple organ failure syndrome
  • Know severe chronic kidney disease (GFR <30mL/min/1,73m²)

Exclusion criteria :

  • During the Coronary computerized tomographic angiogram :
  • Haemodynamic instability requiring high dose of vasopressors (>1µg/kg/min of Norepinephrine)
  • Non sinusal cardiac rhythm
  • KDIGO 1 Acute kidney injury

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients
Other: Coronary Calcium Score and Coronary CT angiogram
Introduction of early Coronary CT angiogram and Coronary Calcium Score in the first days after a resuscitated out-of-hospital cardiac arrest.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Diagnostic accuracy of Coronary Computerized Tomographic Angiogram to rule-out a coronary stenosis > 50%
Time Frame: During hospitalization (maximum 7 days from ICU admission)
During hospitalization (maximum 7 days from ICU admission)

Secondary Outcome Measures

Outcome Measure
Time Frame
Diagnostic accuracy of Coronary Computerized Tomographic Angiogram to rule-out a coronary stenosis > 70%
Time Frame: During hospitalization (maximum 7 days from ICU admission)
During hospitalization (maximum 7 days from ICU admission)
Cororany calcium score associated with coronary stenosis between 50% and 70%
Time Frame: During hospitalization (maximum 7 days from ICU admission)
During hospitalization (maximum 7 days from ICU admission)
Diagnostic accuracy of Coronary Computerized Tomographic Angiogram associated with Coronary Calcium Score compared to CCTA performance alone
Time Frame: During hospitalization (maximum 7 days from ICU admission)
During hospitalization (maximum 7 days from ICU admission)
Incidence of contrast associated acute kidney injury
Time Frame: Day 15
Day 15
Comparison of contrast volume between CCTA and percutaneous coronary intervention
Time Frame: During hospitalization (maximum 7 days from ICU admission)
During hospitalization (maximum 7 days from ICU admission)
Comparison of radiation dose between CCTA and percutaneous coronary intervention
Time Frame: During hospitalization (maximum 7 days from ICU admission)
During hospitalization (maximum 7 days from ICU admission)

Collaborators and Investigators

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

Sponsor

CHU de Reims

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)

March 4, 2024

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

July 18, 2023

First Submitted That Met QC Criteria

July 18, 2023

First Posted (Actual)

July 27, 2023

Study Record Updates

Last Update Posted (Estimated)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PA23075

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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