ClinicalTrials.gg
RecruitingNCT06101862TRACTIONUpdated Feb 19, 2025

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

An interventional study of CCTA and Conventional ICA in Ischemic Heart Disease, Non STEMI and Angina Pectoris, Unstable, sponsored by Rigshospitalet, Denmark. Recruiting at 6 sites in Denmark. Per ClinicalTrials.gov, last updated 2025-02-19.

Sponsored by Rigshospitalet, Denmark · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2023; still recruiting 3 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
2,300
Allocation
Randomized
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 13 studies in Myocardial Ischemia by Rigshospitalet, Denmark — 3 open to participants now, 3 under way, none of them phase 3. Myocardial Ischemia · Rigshospitalet, Denmark.

Planned enrollment
2nd of 12
2,300 · median 54
Started
2023
with 1 other
No phase
5 of 13
2 open now
Registered
13th of 13
by date

Among the 13 studies in Myocardial Ischemia by Rigshospitalet, Denmark, this one is the 2nd largest by planned enrollment of the 12 interventional ones that give a count, is one of 2 that started in 2023, is one of 5 with no phase, and was the 13th registered.

Myocardial Ischemia

1,123 studies on the registry are indexed under Myocardial Ischemia; 177 are open to participants now.

Browse Myocardial Ischemia studies →

Open to participants now

3 of the 13 studies in Myocardial Ischemia by Rigshospitalet, Denmark are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 3 open studies →

Where they have run

Who these studies take

Of the 135 Myocardial Ischemia studies recruiting now, 92 (68%) set no upper age limit and 6 (4%) stop at 75 or younger; 14 take children under 18; 20 take healthy volunteers.

This study: all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 13 studies in Myocardial Ischemia by Rigshospitalet, Denmark, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Ischemic Heart Disease
  • Non STEMI
  • Angina Pectoris, Unstable
  • Coronary Disease
  • Heart Attack
  • Acute Myocardial Infarction (AMI)
  • Randomized Controlled Trial
  • Diagnostic Imaging
  • Coronary Stenoses
  • Coronary Artery Disease
  • Multidetector Computed Tomography
  • Percutaneous Coronary Intervention

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
  • Percutaneous coronary intervention
  • Coronary artery bypass grafting
  • PCI
  • CABG
  • Diagnostic procedure
  • Interhospital transfers
  • Myocardial Ischemia
04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria

Exclusion criteria:

  • Instability requiring acute or emergent ICA
  • History of percutaneous coronary intervention or coronary artery bypass grafting
  • Estimated \< 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
2,300 participants (estimated)

Study arms

  • Active comparator
    Coronary computed tomography angiography + team-based interventional triage

    Procedure: CCTA · Other: Team-based interventional triage

  • Other
    Conventional invasive coronary angiography

    Procedure: Conventional ICA

Interventions

  • ProcedureCCTA

    Participants will be examined with CCTA during admission.

  • ProcedureConventional ICA

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

  • OtherTeam-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.

06

What researchers measure

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.

    Time frame: At 1 year.

Secondary outcomes

  1. 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.

    Time frame: At 1 year.

  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

    Measured by EQ-5D-5L

    Time frame: At 1 year.

  5. Angina symptom burden

    Measured by Seattle Angina Questionnaire

    Time frame: At 1 year.

  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.

07

Study locations

6 of 6 sites recruiting
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — Data will be shared upon reasonable request and uploaded to a repository after the trial has been concluded.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2023 (actual). Primary completion is estimated for Oct 2026, 36 months after the start.

Of 155 non-industry interventional studies with no phase under Myocardial Ischemia, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 56. This study's planned 36 months is close to that.

Counting every sponsor, half of 192 studies reached it within 34 months; a quarter within 15 and three quarters within 58.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 28, 2023
First posted
Oct 26, 2023
StartActual
Oct 1, 2023
Primary completionEst.
Oct 1, 2026
CompletionEst.
Oct 1, 2036
Last update
Feb 19, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06101862
Responsible party
Niels Thue Olsen (Associate Professor, Rigshospitalet, Denmark) — Principal investigator
First posted
Oct 26, 2023
Start date
Oct 1, 2023
Primary completion
Oct 1, 2026 (estimated)
Completion
Oct 1, 2036 (estimated)
Last update
Feb 19, 2025

Study contacts

Niels Thue Olsen, PhD
Contact
niels.thue.olsen@regionh.dk
+45 38 68 38 68

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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