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Recruiting Not applicable

Coronary Computed Tomography Versus Invasive Angiography for Non-ST Elevation Acute Coronary Syndrome

NCT06101862 · tracked via the Priya Life Science Denmark tracker
Phase
Not applicable
Started
2023-10-01
Last updated
2025-02-19

Condition(s) studied

Ischemic Heart DiseaseNon STEMIAngina Pectoris, UnstableCoronary DiseaseHeart AttackAcute Myocardial Infarction (AMI)Randomized Controlled TrialDiagnostic ImagingCoronary StenosesCoronary Artery DiseaseMultidetector Computed TomographyPercutaneous Coronary Intervention

Investigational drug(s) / intervention(s)

CCTAConventional ICATeam-based interventional triage

CCTA: Participants will be examined with CCTA during admission.

Conventional ICA: Patients will be examined with conventional standard-of-care ICA.

Team-based interventional triage: The CCTA will be discussed at a coronary CT-team conference to establish the treatment strategy and provide guidance for any necessary interventional procedure.

Study summary

Coronary computed tomography angiography (CCTA) is a widely accepted initial diagnostic test for individuals suspected of having chronic coronary syndromes. However, there is limited evidence supporting its use in the acute setting. So far, no large-scale randomized trial has examined the performance of CCTA as an alternative to invasive coronary angiography (ICA) in individuals with non-ST-segment elevation myocardial infarction (NSTEACS).

If CCTA were to replace ICA as a routine procedure for individuals with NSTEACS, it could reduce the risk of complications related to ICA, improve patient comfort, expedite decision-making, and reduce healthcare expenses and interhospital transfers.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion criteria: * Admitted with non-ST-segment elevation myocardial infarction or unstable angina pectoris and an indication for subacute ICA * Elevated troponin or ischemic electrocardiographic changes * Written informed consent Exclusion criteria: * Instability requiring acute or emergent ICA * History of percutaneous coronary intervention or coronary artery bypass grafting * Estimated glomerular filtration rate \< 30 mL/min/1.73m2 * Probable type 2 acute myocardial infarction * Severe valvular heart disease as primary diagnosis or potential need for valve intervention * History of spontaneous coronary artery dissection * Expected poor quality of the CCTA * Prior CCTA or ICA during index admission or within 1 week * Known allergy to beta-blockers or contrast agent * Pregnant or nursing * Previously randomized in this trial

Primary outcome measure(s)

  • Number of participants with a combined endpoint of major adverse cardiac events — At 1 year.
    All-cause mortality, non-fatal myocardial infarction, hospitalization with refractory angina, or hospitalization with heart failure.

Trial sites (6)

FacilityCityRegionStatus
Herlev and Gentofte Hospital Copenhagen Hellerup Recruiting
Bispebjerg Hospital Bispebjerg Denmark Recruiting
Rigshospitalet Copenhagen Denmark Recruiting
Zealand University Hospital Copenhagen Denmark Recruiting
North Zealand Hospital Hillerød Denmark Recruiting
Hvidovre Hospital Hvidovre Denmark Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06101862 on ClinicalTrials.gov ↗ ← All trials in Denmark