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Recruiting NCT06101862

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

No phase Interventional Ischemic Heart Disease Non STEMI Angina Pectoris, Unstable Coronary Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CCTA, Conventional ICA, Team-based interventional triage.
Who it may be relevant to
Registry conditions: Ischemic Heart Disease, Non STEMI, Angina Pectoris, Unstable, Coronary Disease. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Procedure CCTA
    Participants will be examined with CCTA during admission.
  • Procedure Conventional ICA
    Patients will be examined with conventional standard-of-care ICA.
  • 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.

Primary outcome measures

  • Number of participants with a combined endpoint of major adverse cardiac events [Time frame: At 1 year.]
Secondary outcome measures (7)
  • Number of participants with a the individual composites of the primary outcome [Time frame: At 1 year.]
  • Number of participants with cardiovascular death [Time frame: At 1 year.]
  • Number of participants with unplanned coronary revascularization [Time frame: At 1 year.]
  • Health-related Quality of life [Time frame: At 1 year.]
  • Angina symptom burden [Time frame: At 1 year.]
  • Total (cumulative) radiation dosage during index admission [Time frame: At 1st hospital discharge, an average of 2 days.]
  • Length of index hospitalization [Time frame: At 1st hospital discharge, an average of 2 days.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Denmark · 6 centers
  • Herlev and Gentofte Hospital — Copenhagen
  • Bispebjerg Hospital — Bispebjerg
  • Rigshospitalet — Copenhagen
  • Zealand University Hospital — Copenhagen
  • North Zealand Hospital — Hillerød
  • Hvidovre Hospital — Hvidovre

Publications

  • Sorgaard MH, Kristensen AT, Eskesen K, Kofoed KF, Linde JJ, Kelbaek H, Ottesen M, Neland K, Kragelund C, Bertelsen MLN, Hove JD, Mork G, Kristiansen OP, Engstrom T, Lonborg JT, Kuhl JT, Risom SS, Blanche P, Olsen NT. Coronary computed tomography angiography versus invasive coronary angiography for interventional triage in acute coronary syndrome: Design of the randomized TRACTION trial. Am Heart J PMID 41360328

Identifiers

NCT: NCT06101862 · H-23024848

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗