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NCT Number: NCT05961488

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coronary Calcium Score and Coronary CT angiogram

Other

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

Primary outcomes

  1. 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 outcomes

  1. Diagnostic accuracy of Coronary Computerized Tomographic Angiogram to rule-out a coronary stenosis > 70%

    Time frame: During hospitalization (maximum 7 days from ICU admission)

  2. Cororany calcium score associated with coronary stenosis between 50% and 70%

    Time frame: During hospitalization (maximum 7 days from ICU admission)

  3. 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)

  4. Incidence of contrast associated acute kidney injury

    Time frame: Day 15

  5. Comparison of contrast volume between CCTA and percutaneous coronary intervention

    Time frame: During hospitalization (maximum 7 days from ICU admission)

  6. Comparison of radiation dose between CCTA and percutaneous coronary intervention

    Time frame: During hospitalization (maximum 7 days from ICU admission)

Study contacts

Contact information is provided by the study sponsor or research team.

Antoine GOURY

CONTACT

[email protected]

03 10 73 68 85 ext. 0033

Bruno MOURVILLIER

CONTACT

[email protected]

03 10 73 66 20 ext. 0033

Sponsors and collaborators

Lead sponsor

CHU de Reims

Other

Registry information

Acronym: PERFECCT

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Jul 27, 2023
Registry last updated
Mar 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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