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

NCT ID: NCT05961488

Last Updated: 2024-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-04

Study Completion Date

2028-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Out of Hospital Cardiac Arrest Without ST-segment Elevation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients

Group Type EXPERIMENTAL

Coronary Calcium Score and Coronary CT angiogram

Intervention Type OTHER

Introduction of early Coronary CT angiogram and Coronary Calcium Score in the first days after a resuscitated out-of-hospital cardiac arrest.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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


* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

CHU de Reims

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Damien JOLLY

Reims, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Antoine GOURY

Role: CONTACT

03 10 73 68 85 ext. 0033

Bruno MOURVILLIER

Role: CONTACT

03 10 73 66 20 ext. 0033

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Antoine GOURY

Role: primary

03 10 73 68 85 ext. 0033

Bruno MOURVILLIER

Role: backup

03 10 73 66 20 ext. 0033

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PA23075

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.