RecruitingNot ApplicableNCT06101862

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

Team-based Interventional Triage in Acute Coronary Syndrome Based on Non-Invasive Computed Tomography Coronary Angiography - a Randomized Trial

Sponsor

Rigshospitalet, Denmark

Enrollment

2,300 participants

Start Date

Oct 1, 2023

Study Type

INTERVENTIONAL

Conditions

Coronary Disease Randomized Controlled Trial Diagnostic Imaging Coronary Artery Disease Ischemic Heart Disease Heart Attack Percutaneous Coronary Intervention Acute Myocardial Infarction (AMI)Non STEMI Angina Pectoris, Unstable Coronary Stenoses Multidetector Computed Tomography

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

Inclusion Criteria3

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 Criteria11

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

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Interventions

PROCEDURECCTA

Participants will be examined with CCTA during admission.

PROCEDUREConventional ICA

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

OTHERTeam-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.