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

February 14, 2025 updated by: Niels Thue Olsen, Rigshospitalet, Denmark

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

2300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with a combined endpoint of major adverse cardiac events
Time Frame: At 1 year.
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
Angina symptom burden
Time Frame: At 1 year.
Measured by Seattle Angina Questionnaire
At 1 year.
Health-related Quality of life
Time Frame: At 1 year.
Measured by EQ-5D-5L
At 1 year.
Length of index hospitalization
Time Frame: At 1st hospital discharge, an average of 2 days.
At 1st hospital discharge, an average of 2 days.
Number of participants with a the individual composites of the primary outcome
Time Frame: At 1 year.
All-cause mortality, non-fatal myocardial infarction, hospitalization with refractory angina, or hospitalization with heart failure.
At 1 year.
Number of participants with cardiovascular death
Time Frame: At 1 year.
At 1 year.
Number of participants with unplanned coronary revascularization
Time Frame: At 1 year.
At 1 year.
Total (cumulative) radiation dosage during index admission
Time Frame: At 1st hospital discharge, an average of 2 days.
At 1st hospital discharge, an average of 2 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Collaborators

University of Copenhagen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2036

Study Registration Dates

First Submitted

September 28, 2023

First Submitted That Met QC Criteria

October 20, 2023

First Posted (Actual)

October 26, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 14, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-23024848

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be shared upon reasonable request and uploaded to a repository after the trial has been concluded.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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