NCT06101862

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,300

participants targeted

Target at P75+ for not_applicable

Timeline
126mo left

Started Oct 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress20%
Oct 2023Oct 2036

First Submitted

Initial submission to the registry

September 28, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

October 26, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
10 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2036

Last Updated

February 19, 2025

Status Verified

February 1, 2025

Enrollment Period

3 years

First QC Date

September 28, 2023

Last Update Submit

February 14, 2025

Conditions

Keywords

AngiographyComputed TomographyCoronaryNon-STEACSCCTAICARandomizedInterventional TriageTRACTIONDiagnostic imagingInterventional cardiologyVERDICTCTCoronary AngiographyComplicationsCoronary CT-teamIschemic heart diseaseAcute myocardial infarctionNon-ST-elevation myocardial infarction (NSTEMI)Unstable angina pectorisPercutaneous coronary interventionCoronary artery bypass graftingPCICABGDiagnostic procedureInterhospital transfersMyocardial Ischemia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Number of participants with a the individual composites of the primary outcome

    At 1 year.

  • Number of participants with cardiovascular death

    At 1 year.

  • Number of participants with unplanned coronary revascularization

    At 1 year.

  • Health-related Quality of life

    At 1 year.

  • Angina symptom burden

    At 1 year.

  • +2 more secondary outcomes

Study Arms (2)

Coronary computed tomography angiography + team-based interventional triage

ACTIVE COMPARATOR
Procedure: CCTAOther: Team-based interventional triage

Conventional invasive coronary angiography

OTHER
Procedure: Conventional ICA

Interventions

CCTAPROCEDURE

Participants will be examined with CCTA during admission.

Coronary computed tomography angiography + team-based interventional triage

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

Conventional invasive coronary angiography

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

Coronary computed tomography angiography + team-based interventional triage

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Herlev and Gentofte Hospital

Copenhagen, Hellerup, 2900, Denmark

RECRUITING

Bispebjerg Hospital

Bispebjerg, Denmark

RECRUITING

Rigshospitalet

Copenhagen, Denmark

RECRUITING

Zealand University Hospital

Copenhagen, Denmark

RECRUITING

North Zealand Hospital

Hillerød, Denmark

RECRUITING

Hvidovre Hospital

Hvidovre, Denmark

RECRUITING

Related Publications (1)

  • 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. 2025 Dec 6;294:107325. doi: 10.1016/j.ahj.2025.107325. Online ahead of print.

MeSH Terms

Conditions

Myocardial IschemiaNon-ST Elevated Myocardial InfarctionAngina, UnstableCoronary DiseaseMyocardial InfarctionCoronary StenosisCoronary Artery Disease

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisAngina PectorisChest PainPainNeurologic ManifestationsSigns and SymptomsArteriosclerosisArterial Occlusive Diseases

Central Study Contacts

Niels Thue Olsen, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 28, 2023

First Posted

October 26, 2023

Study Start

October 1, 2023

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2036

Last Updated

February 19, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share

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

Locations