Health TrialsbyHealthPanel

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

ConditionsIschemic Heart DiseaseNon STEMIAngina Pectoris, UnstableCoronary DiseaseHeart AttackAcute Myocardial Infarction (AMI)Randomized Controlled TrialDiagnostic ImagingCoronary StenosesCoronary Artery DiseaseMultidetector Computed TomographyPercutaneous Coronary Intervention
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorRigshospitalet, Denmark

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • CCTA

    Procedure/Surgery

    Participants will be examined with CCTA during admission.

  • Conventional ICA

    Procedure/Surgery

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

  • Team-based interventional triage

    Other intervention

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

Treatment groups

2,300 Participants
are divided into 2 treatment groups
Group A: Coronary computed tomography angiography + team-based interventional triageActive comparator 2 interventions
Group B: Conventional invasive coronary angiographyOther 1 intervention

Trial outcomes

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rigshospitalet, Denmark

Lead sponsor

University of Copenhagen

Collaborator

Source ClinicalTrials.gov
Apply now