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NCT Number: NCT06101862

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

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.

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Key information

Conditions

Ischemic Heart Disease Acute Myocardial Infarction (AMI) Angina Pectoris Angina Pectoris, Unstable Angina, Unstable Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Chest Pain Coronary Artery Disease Coronary Disease Coronary Stenoses Coronary Stenosis Diagnostic Imaging Heart Attack Heart Diseases Infarction Ischemia Multidetector Computed Tomography Myocardial Infarction Myocardial Ischemia Necrosis Neurologic Manifestations Non STEMI Non-ST Elevated Myocardial Infarction Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Percutaneous Coronary Intervention Randomized Controlled Trial Signs and Symptoms Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Herlev and Gentofte Hospital, Copenhagen, Hellerup, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CCTA

Procedure

Participants will be examined with CCTA during admission.

Conventional ICA

Procedure

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

Team-based interventional triage

Other

The CCTA will be discussed at a coronary CT-team conference to establish the treatment strategy and provide guidance for any necessary interventional procedure.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Number of participants with cardiovascular death

    Time frame: At 1 year.

  3. Number of participants with unplanned coronary revascularization

    Time frame: At 1 year.

  4. Health-related Quality of life

    Time frame: At 1 year.

    Measured by EQ-5D-5L

  5. Angina symptom burden

    Time frame: At 1 year.

    Measured by Seattle Angina Questionnaire

  6. Total (cumulative) radiation dosage during index admission

    Time frame: At 1st hospital discharge, an average of 2 days.

  7. Length of index hospitalization

    Time frame: At 1st hospital discharge, an average of 2 days.

Study contacts

Contact information is provided by the study sponsor or research team.

Niels Thue Olsen, PhD

CONTACT

[email protected]

+45 38 68 38 68

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • University of Copenhagen

Registry information

Official study title

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

Acronym: TRACTION

Important dates

Study start
2023
Primary completion
2026
Study completion
2036
First posted
Oct 26, 2023
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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