Clinical trial NCT05961488: Performance of Coronary CT Angiography to Rule Out Coronary Artery Disease After Out-of-hospital Cardiac Arrest
Official title: Performance of Coronary CT Angiography to Rule Out Coronary Artery Disease After Out-of-hospital Cardiac Arrest
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Out of Hospital Cardiac Arrest Without ST-segment Elevation
Keywords: Cardiac arrest
Diagnostic accuracy
Coronary computarized tomography angiogram
Coronary Calcium Score
Non-ST Elevated Myocardial Infarction
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic accuracy of Coronary Computerized Tomographic Angiogram to rule-out a coronary stenosis > 50%
timeFrame: During hospitalization (maximum 7 days from ICU admission)
Secondary outcomes:
measure: Diagnostic accuracy of Coronary Computerized Tomographic Angiogram to rule-out a coronary stenosis > 70%
timeFrame: During hospitalization (maximum 7 days from ICU admission)
measure: Cororany calcium score associated with coronary stenosis between 50% and 70%
timeFrame: During hospitalization (maximum 7 days from ICU admission)
measure: Diagnostic accuracy of Coronary Computerized Tomographic Angiogram associated with Coronary Calcium Score compared to CCTA performance alone
timeFrame: During hospitalization (maximum 7 days from ICU admission)
measure: Incidence of contrast associated acute kidney injury
timeFrame: Day 15
measure: Comparison of contrast volume between CCTA and percutaneous coronary intervention
timeFrame: During hospitalization (maximum 7 days from ICU admission)
measure: Comparison of radiation dose between CCTA and percutaneous coronary intervention
timeFrame: During hospitalization (maximum 7 days from ICU admission)
Other outcomes:
Locations:
city: Reims
country: France
facility: Damien JOLLY
Study officials:
References: