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

Sponsor

CHU de Reims (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05961488

Collaborator

(none)

200

Enrollment

Location

Arm

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Out of Hospital Cardiac Arrest Without ST-segment Elevation	Other: Coronary Calcium Score and Coronary CT angiogram	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2024

Anticipated Primary Completion Date :

Oct 1, 2027

Anticipated Study Completion Date :

Jan 1, 2028

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Diagnostic accuracy of Coronary Computerized Tomographic Angiogram to rule-out a coronary stenosis > 50% [During hospitalization (maximum 7 days from ICU admission)]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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