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

Study Overview
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Brief Summary
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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.

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

Conditions
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Ischemic Heart Disease, Non STEMI, Angina Pectoris, Unstable

Intervention / Treatment
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* Procedure: CCTA
* Procedure: Conventional ICA
* Other: Team-based interventional triage


Participation Criteria
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Eligibility Criteria
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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 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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Coronary computed tomography angiography + team-based interventional triage<br> | Procedure: CCTA<br>* Participants will be examined during admission.<br>Other: Team-based interventional triage<br>* If the CCTA suggests a potential requirement for revascularization, the CCTA will be discussed at a coronary CT-team conference to establish the treatment strategy and provide guidance for any necessary interventional procedure.<br>|
| Other: Conventional invasive coronary angiography<br> | Procedure: Conventional ICA<br>* Standard-of-care with conventional ICA.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with a combined endpoint of major adverse cardiac events | All-cause mortality, non-fatal myocardial infarction, hospitalization with refractory angina, or hospitalization with heart failure. | At 1 year. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with a combined endpoint of major adverse cardiac events | All-cause mortality, non-fatal myocardial infarction, hospitalization with refractory angina, or hospitalization with heart failure. | At 1st hospital discharge, an average of 2 days, and at 30 days. | 
| Number of participants with all-cause mortality |  | At 1st hospital discharge, an average of 2 days, at 30 days, and at 1 year. | 
| Number of participants with non-fatal myocardial infarction |  | At 1st hospital discharge, an average of 2 days, at 30 days, and at 1 year. | 
| Number of participants with hospitalization with refractory angina |  | At 1st hospital discharge, an average of 2 days, at 30 days, and at 1 year. | 
| Number of participants with hospitalization with heart failure. |  | At 1st hospital discharge, an average of 2 days, at 30 days, and at 1 year. | 
| Number of participants with stroke |  | At 1st hospital discharge, an average of 2 days, at 30 days, and at 1 year. | 
| Number of participants with cardiovascular death |  | At 1st hospital discharge, an average of 2 days, at 30 days, and at 1 year. | 
| Number of participants with serious adverse events |  | At 1st hospital discharge, an average of 2 days. | 
| Number of participants with procedure-related complications |  | At 1st hospital discharge, an average of 2 days, at 30 days, and at 1 year. | 
| Number of participants with bleeding according to Bleeding Academic Research Consortium |  | At 1st hospital discharge, an average of 2 days, at 30 days, and at 1 year. | 
| Number of participants with coronary revascularization |  | At 1st hospital discharge, an average of 2 days, at 30 days, and at 1 year. | 
| Number of participants with hospitalization for any cardiac reason or related to cardiovascular treatment |  | At 1 year | 
| Number of participants with any invasive or non-invasive examination for ischemic heart disease |  | At 1st hospital discharge, an average of 2 day, and at 1 year. | 
| Costs of index admission, cardiovascular visits and admissions, and procedures |  | At 1 year. | 
| Angina symptom burden | Measured by Seattle Angina Questionnaire | At 1 year. | 
| Health-related Quality of life | Measured by EQ-5D-5L | At 1 year. | 
| Length of index hospitalization |  | At 1st hospital discharge, an average of 2 days. | 
| Time from index hospitalization to examination |  | At examination, an average of 1 day. | 
| Radiation dosage of all cardiac diagnostic examinations and interventions |  | At 1st hospital discharge, an average of 2 days, and at 1 year. | 
| Fluoroscopy time |  | At 1st hospital discharge, an average of 2 days. | 
| Procedure time |  | At 1st hospital discharge, an average of 2 days. | 
| Contrast use |  | At 1st hospital discharge, an average of 2 days. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Angiography, Computed Tomography, Coronary, Non-STEACS