Ischemic Heart DiseaseTRACTIONNCT06101862
Coronary Computed Tomography Versus Invasive Angiography for Non-ST Elevation Acute Coronary Syndrome
A study testing CCTA, Conventional ICA and Team-based interventional triage in people with Ischemic Heart Disease and Non STEMI, run by Copenhagen University Hospital, Rigshospitalet at 6 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ischemic Heart Disease, Non STEMI, Angina Pectoris, Unstable
- What is being tested?
- CCTA, Conventional ICA and Team-based interventional triage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,300 participants
- Where
- 6 sitesDenmark
- Study dates
- 1 Oct 2023to 1 Oct 2036
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Denmark6 sites, 6 recruiting
- Recruiting
Bispebjerg Hospital
Bispebjerg
Gorm Mørk, 38 63 61 74 ext. 45, fh-dv@regionh.dk
- Recruiting
Herlev and Gentofte Hospital
Copenhagen, Hellerup, 2900
Kristian Eskesen, 38 67 38 67 ext. 45, niels.thue.olsen@regionh.dk
- Recruiting
Rigshospitalet
Copenhagen
Niels Thue Olsen, 38 63 38 63 ext. 45, rigshospital.rigshospitalet@regionh.dk
- Recruiting
Zealand University Hospital
Copenhagen
Henning Kofoed, 46 32 32 00 ext. 45, suh@regionsjaelland.dk
- Recruiting
North Zealand Hospital
Hillerød
Charlotte Kragelund, 48 29 50 00 ext. 45, noh.nordsjaellands-hospital@regionh.dk
- Recruiting
Hvidovre Hospital
Hvidovre
Jens Hove, 38 62 38 62 ext. 45, jens.dahlgaard.hove@regionh.dk
About this study
Official title: 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.
- Conditions
- Ischemic Heart Disease, Non STEMI, Angina Pectoris, Unstable, Coronary Disease, Heart Attack, Acute Myocardial Infarction (AMI)
- Being tested
- CCTA, Conventional ICA, Team-based interventional triage
- Keywords
- Angiography, Computed Tomography, Coronary, Non-STEACS, CCTA, ICA, Randomized, Interventional Triage, TRACTION, Diagnostic imaging, Interventional cardiology, VERDICT, CT, Coronary Angiography, Complications, Coronary CT-team, Ischemic heart disease, Acute myocardial infarction, Non-ST-elevation myocardial infarction (NSTEMI), Unstable angina pectoris
- Medical subject headings
- Myocardial Ischemia, Non-ST Elevated Myocardial Infarction, Angina, Unstable, Coronary Disease, Myocardial Infarction, Coronary Stenosis, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CCTAProcedure or surgery
Participants will be examined with CCTA during admission.
Conventional ICAProcedure or surgery
Patients will be examined with conventional standard-of-care ICA.
Team-based interventional triageOther
The CCTA will be discussed at a coronary CT-team conference to establish the treatment strategy and provide guidance for any necessary interventional procedure.
| Study group | Role | What they receive |
|---|---|---|
| Coronary computed tomography angiography + team-based interventional triage | Active comparator | Not described Receives: Procedure: CCTA; Other: Team-based interventional triage |
| Conventional invasive coronary angiography | Other | Not described Receives: Procedure: Conventional ICA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 1 year.
Secondary outcomes (7)
Number of participants with a the individual composites of the primary outcome
All-cause mortality, non-fatal myocardial infarction, hospitalization with refractory angina, or hospitalization with heart failure.
Measured: At 1 year.
Number of participants with cardiovascular death
Measured: At 1 year.
Number of participants with unplanned coronary revascularization
Measured: At 1 year.
Health-related Quality of life
Measured by EQ-5D-5L
Measured: At 1 year.
Angina symptom burden
Measured by Seattle Angina Questionnaire
Measured: At 1 year.
Total (cumulative) radiation dosage during index admission
Measured: At 1st hospital discharge, an average of 2 days.
Length of index hospitalization
Measured: At 1st hospital discharge, an average of 2 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start1 Oct 2023
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Principal investigator, Niels Thue Olsen, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06101862
- Sponsor's protocol ID
- H-23024848
- Acronym
- TRACTION
- Status last verified
- Feb 2025
- First submitted
- 28 Sep 2023
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared upon reasonable request and uploaded to a repository after the trial has been concluded.
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. 2026 Apr;294:107325. doi: 10.1016/j.ahj.2025.107325. Epub 2025 Dec 6.
PubMed 41360328
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Team-based Interventional Triage in Acute Coronary Syndrome Based on Non-Invasive Computed Tomography Coronary Angiography - a Randomized Trial
- ClinicalTrials.gov ID
- NCT06101862
- Acronym / sponsor ID
- TRACTION / H-23024848
- Conditions
- Ischemic Heart Disease, Non STEMI, Angina Pectoris, Unstable, Coronary Disease, Heart Attack, Acute Myocardial Infarction (AMI)
- Keywords
- Angiography, Computed Tomography, Coronary, Non-STEACS, CCTA, ICA, Randomized, Interventional Triage
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,300 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2036 (estimated)
- First posted
- 26 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coronary computed tomography angiography + team-based interventional triage | Active comparator | Procedure: CCTA, Other: Team-based interventional triage |
| Conventional invasive coronary angiography | Other | Procedure: Conventional ICA |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CCTAParticipants will be examined with CCTA during admission. | Procedure or surgery | Coronary computed tomography angiography + team-based interventional triage |
| Conventional ICAPatients will be examined with conventional standard-of-care ICA. | Procedure or surgery | Conventional invasive coronary angiography |
| Team-based interventional triageThe CCTA will be discussed at a coronary CT-team conference to establish the treatment strategy and provide guidance for any necessary interventional procedure. | Other | Coronary computed tomography angiography + team-based interventional triage |
Primary outcome
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.
7 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Derived from this study: PubMed 41360328Sorgaard 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. 2026 Apr;294:107325. doi: 10.1016/j.ahj.2025.107325. Epub 2025 Dec 6.
- Individual participant dataSharing planned: Yes. Data will be shared upon reasonable request and uploaded to a repository after the trial has been concluded.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CCTA, Conventional ICA and Team-based interventional triage in people with Ischemic Heart Disease and Non STEMI, run by Copenhagen University Hospital, Rigshospitalet at 6 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Niels Thue Olsen, PhD (+45 38 68 38 68, niels.thue.olsen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with a combined endpoint of major adverse cardiac events (time frame: At 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06101862, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.