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

Sponsor

Herlev and Gentofte Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT06101862

Collaborator

Rigshospitalet, Denmark (Other), Zealand University Hospital (Other), North Zealand Hospital, Denmark (Other), Amager Hospital (Other), Bispebjerg Hospital (Other), Hvidovre University Hospital (Other)

2,300

Enrollment

Location

Arms

156

Anticipated Duration (Months)

14.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ischemic Heart Disease Non STEMI Angina Pectoris, Unstable	Procedure: CCTA Procedure: Conventional ICA Other: Team-based interventional triage	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

2300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2026

Anticipated Study Completion Date :

Oct 1, 2036

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Coronary computed tomography angiography + team-based interventional triage	Procedure: CCTA Participants will be examined during admission. Other: Team-based interventional triage 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.
Other: Conventional invasive coronary angiography	Procedure: Conventional ICA Standard-of-care with conventional ICA.

Arm

Intervention/Treatment

Active Comparator: Coronary computed tomography angiography + team-based interventional triage

Procedure: CCTA

Participants will be examined during admission.

Other: Team-based interventional triage

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.

Other: Conventional invasive coronary angiography

Procedure: Conventional ICA

Standard-of-care with conventional ICA.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Number of participants with a combined endpoint of major adverse cardiac events [At 1st hospital discharge, an average of 2 days, and at 30 days.]
All-cause mortality, non-fatal myocardial infarction, hospitalization with refractory angina, or hospitalization with heart failure.
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 [At 1 year.]
Measured by Seattle Angina Questionnaire
Health-related Quality of life [At 1 year.]
Measured by EQ-5D-5L
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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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