Actively Recruiting

Phase Not Applicable
All Genders
ID06101862

Team-based Interventional Triage in Acute Coronary Syndrome Using Non-Invasive Computed Tomography Coronary Angiography Compared to Invasive Angiography

Led by Rigshospitalet, Denmark · Updated on 2025-02-19

2300

Participants Needed

6

Research Sites

521 weeks

Total Duration

On this page

Sponsors

R

Rigshospitalet, Denmark

Lead Sponsor

U

University of Copenhagen

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating whether coronary computed tomography angiography (CCTA) can be used instead of invasive coronary angiography (ICA) for people with non-ST-segment elevation acute coronary syndrome (NSTEACS). This study aims to see if CCTA can safely and effectively guide treatment decisions, potentially reducing complications, improving comfort, speeding up care, and lowering costs compared to the traditional invasive approach. The trial is randomized and evaluates outcomes in individuals suspected of having this heart condition. Participants are assigned to one of two groups: one group receives CCTA plus team-based interventional triage, where a specialized team reviews the CCTA results to plan treatment; the other group receives the standard conventional ICA. Both procedures occur during hospital admission. The study monitors participants over time to compare these diagnostic and treatment strategies. During the study, researchers will track major heart-related events over one year, including heart attacks, death from cardiovascular causes, and need for unplanned procedures. They will also evaluate quality of life, angina symptoms, radiation exposure during hospital stay, and length of hospitalization. Participants provide informed consent and receive follow-up assessments to measure these outcomes and ensure safety throughout the trial.

CONDITIONS

Brief Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Admitted with non-ST-segment elevation myocardial infarction or unstable angina pectoris and an indication for subacute invasive coronary angiography
  • Elevated troponin levels or ischemic electrocardiographic changes
  • Ability to provide written informed consent
Not Eligible

You will not qualify if you...

  • Instability requiring acute or emergent invasive coronary angiography
  • History of percutaneous coronary intervention or coronary artery bypass grafting
  • Estimated glomerular filtration rate less than 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 coronary computed tomography angiography
  • Prior coronary computed tomography angiography or invasive coronary angiography during index admission or within 1 week
  • Known allergy to beta-blockers or contrast agent
  • Pregnant or nursing
  • Previously randomized in this trial

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for eligibility assessment

Treatment

Duration - Approximately 2 days (length of index hospitalization)

Participants undergo either coronary computed tomography angiography (CCTA) with team-based interventional triage or conventional invasive coronary angiography (ICA) to guide treatment decisions during hospital admission.

1 hospital admission visit including imaging and treatment procedures

Follow-up

Duration - Up to 1 year

Participants are monitored for major adverse cardiac events, cardiovascular outcomes, quality of life, and symptom burden for up to 1 year after treatment.

Follow-up assessments at intervals during the 1 year after treatment

Trial Site Locations

Total: 6 locations

1

Herlev and Gentofte Hospital

Copenhagen, Hellerup, Denmark, 2900

Actively Recruiting

2

Bispebjerg Hospital

Bispebjerg, Denmark

Actively Recruiting

3

Rigshospitalet

Copenhagen, Denmark

Actively Recruiting

4

Zealand University Hospital

Copenhagen, Denmark

Actively Recruiting

5

North Zealand Hospital

Hillerød, Denmark

Actively Recruiting

6

Hvidovre Hospital

Hvidovre, Denmark

Actively Recruiting

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Research Team

N

Niels Thue Olsen, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Coronary computed tomography angiography versus invasive coronary angiography for interventional triage in acute coronary syndrome: Design of the randomized TRACTION trial.

Mathias Holm Sørgaard, Andreas Torp Kristensen, Kristian Eskesen...

https://pubmed.ncbi.nlm.nih.gov/41360328