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

Primary Purpose

Out of Hospital Cardiac Arrest Without ST-segment Elevation

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Coronary Calcium Score and Coronary CT angiogram
Sponsored by
CHU de Reims
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Out of Hospital Cardiac Arrest Without ST-segment Elevation focused on measuring Cardiac arrest, Diagnostic accuracy, Coronary computarized tomography angiogram, Coronary Calcium Score, Non-ST Elevated Myocardial Infarction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Damien JOLLY

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients

Arm Description

Outcomes

Primary Outcome Measures

Diagnostic accuracy of Coronary Computerized Tomographic Angiogram to rule-out a coronary stenosis > 50%

Secondary Outcome Measures

Diagnostic accuracy of Coronary Computerized Tomographic Angiogram to rule-out a coronary stenosis > 70%
Cororany calcium score associated with coronary stenosis between 50% and 70%
Diagnostic accuracy of Coronary Computerized Tomographic Angiogram associated with Coronary Calcium Score compared to CCTA performance alone
Incidence of contrast associated acute kidney injury
Comparison of contrast volume between CCTA and percutaneous coronary intervention
Comparison of radiation dose between CCTA and percutaneous coronary intervention

Full Information

First Posted
July 18, 2023
Last Updated
July 18, 2023
Sponsor
CHU de Reims
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1. Study Identification

Unique Protocol Identification Number
NCT05961488
Brief Title
Performance of Coronary CT Angiography to Rule Out Coronary Artery Disease After Out-of-hospital Cardiac Arrest
Acronym
PERFECCT
Official Title
Performance of Coronary CT Angiography to Rule Out Coronary Artery Disease After Out-of-hospital Cardiac Arrest
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2024 (Anticipated)
Primary Completion Date
October 2027 (Anticipated)
Study Completion Date
January 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Reims

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Coronary Calcium Score and Coronary CT angiogram
Intervention Description
Introduction of early Coronary CT angiogram and Coronary Calcium Score in the first days after a resuscitated out-of-hospital cardiac arrest.
Primary Outcome Measure Information:
Title
Diagnostic accuracy of Coronary Computerized Tomographic Angiogram to rule-out a coronary stenosis > 50%
Time Frame
During hospitalization (maximum 7 days from ICU admission)
Secondary Outcome Measure Information:
Title
Diagnostic accuracy of Coronary Computerized Tomographic Angiogram to rule-out a coronary stenosis > 70%
Time Frame
During hospitalization (maximum 7 days from ICU admission)
Title
Cororany calcium score associated with coronary stenosis between 50% and 70%
Time Frame
During hospitalization (maximum 7 days from ICU admission)
Title
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)
Title
Incidence of contrast associated acute kidney injury
Time Frame
Day 15
Title
Comparison of contrast volume between CCTA and percutaneous coronary intervention
Time Frame
During hospitalization (maximum 7 days from ICU admission)
Title
Comparison of radiation dose between CCTA and percutaneous coronary intervention
Time Frame
During hospitalization (maximum 7 days from ICU admission)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antoine GOURY
Phone
03 10 73 68 85
Ext
0033
Email
agoury@chu-reims.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Bruno MOURVILLIER
Phone
03 10 73 66 20
Ext
0033
Email
bmourvillier@chu-reims.fr
Facility Information:
Facility Name
Damien JOLLY
City
Reims
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antoine GOURY
Phone
03 10 73 68 85
Ext
0033
Email
agoury@chu-reims.fr
First Name & Middle Initial & Last Name & Degree
Bruno MOURVILLIER
Phone
03 10 73 66 20
Ext
0033
Email
bmourvillier@chu-reims.fr

12. IPD Sharing Statement

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

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