Clinical trial NCT06101862: Coronary Computed Tomography Versus Invasive Angiography for Non-ST Elevation Acute Coronary Syndrome
Official title: Team-based Interventional Triage in Acute Coronary Syndrome Based on Non-Invasive Computed Tomography Coronary Angiography - a Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: 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
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2023-10-26
Enrollment: 2300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 informed consent

Exclusion criteria:

* Instability requiring acute or emergent ICA
* History of percutaneous coronary intervention or coronary artery bypass grafting
* Estimated glomerular filtration rate \&lt; 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

Primary outcomes:
measure: Number of participants with a combined endpoint of major adverse cardiac events
timeFrame: At 1 year.
Secondary outcomes:
measure: Number of participants with a the individual composites of the primary outcome
timeFrame: At 1 year.
measure: Number of participants with cardiovascular death
timeFrame: At 1 year.
measure: Number of participants with unplanned coronary revascularization
timeFrame: At 1 year.
measure: Health-related Quality of life
timeFrame: At 1 year.
measure: Angina symptom burden
timeFrame: At 1 year.
measure: Total (cumulative) radiation dosage during index admission
timeFrame: At 1st hospital discharge, an average of 2 days.
measure: Length of index hospitalization
timeFrame: At 1st hospital discharge, an average of 2 days.
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Herlev and Gentofte Hospital
state: Hellerup
city: Bispebjerg
country: Denmark
facility: Bispebjerg Hospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Copenhagen
country: Denmark
facility: Zealand University Hospital
city: Hillerød
country: Denmark
facility: North Zealand Hospital
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
Study officials:
References: