Acute Myocardial Infarction (AMI), Angina Pectoris, Unstable, Coronary Artery Disease, Coronary Disease, Coronary Stenoses, Diagnostic Imaging, Heart Attack, Ischemic Heart Disease, Multidetector Computed Tomography, Non STEMI, Percutaneous Coronary Intervention, Randomized Controlled Trial
Conditions
Keywords
Angiography, Computed Tomography, Coronary, Non-STEACS, CCTA, ICA, Randomized, Interventional Triage, TRACTION, Diagnostic imaging, Interventional cardiology, VERDICT, CT, Coronary Angiography, Complications, Coronary CT-team, Ischemic heart disease, Acute myocardial infarction, Non-ST-elevation myocardial infarction (NSTEMI), Unstable angina pectoris, Percutaneous coronary intervention, Coronary artery bypass grafting, PCI, CABG, Diagnostic procedure, Interhospital transfers, Myocardial Ischemia
Brief 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.
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.
Sponsors
University of Copenhagen
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with cardiovascular death | At 1 year. | — |
| Number of participants with unplanned coronary revascularization | At 1 year. | — |
| Health-related Quality of life | At 1 year. | Measured by EQ-5D-5L |
| Number of participants with a the individual composites of the primary outcome | At 1 year. | All-cause mortality, non-fatal myocardial infarction, hospitalization with refractory angina, or hospitalization with heart failure. |
| Total (cumulative) radiation dosage during index admission | At 1st hospital discharge, an average of 2 days. | — |
| Length of index hospitalization | At 1st hospital discharge, an average of 2 days. | — |
| Angina symptom burden | At 1 year. | Measured by Seattle Angina Questionnaire |
Countries
Denmark
Contacts
Primary ContactNiels Thue Olsen, PhD
Outcome results
None listed