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

Not Applicable

Recruiting

• 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
• Interventions: Procedure: CCTA; Procedure: Conventional ICA; Other: Team-based interventional triage

• Registration Number: NCT06101862
• Lead Sponsor: Rigshospitalet, Denmark

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-28
• Study Start: 2023-10-01
• Study First Submitted QC: 2023-10-20
• Study First Posted: 2023-10-26
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-14
• Last Update Posted: 2025-03-25
• Primary Completion: 2026-10-01
• Study Completion: 2036-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Coronary computed tomography angiography + team-based interventional triage	CCTA	-
Coronary computed tomography angiography + team-based interventional triage	Team-based interventional triage	-
Conventional invasive coronary angiography	Conventional ICA	-

Primary Outcome Measures

Name	Time	Method
Number of participants with a combined endpoint of major adverse cardiac events	At 1 year.	All-cause mortality, non-fatal myocardial infarction, hospitalization with refractory angina, or hospitalization with heart failure.

Secondary Outcome Measures

Name	Time	Method
Number of participants with unplanned coronary revascularization	At 1 year.
Health-related Quality of life	At 1 year.	Measured by EQ-5D-5L
Angina symptom burden	At 1 year.	Measured by Seattle Angina Questionnaire
Total (cumulative) radiation dosage during index admission	At 1st hospital discharge, an average of 2 days.
Length of index hospitalization	At 1st hospital discharge, an average of 2 days.
Number of participants with cardiovascular death	At 1 year.
Number of participants with a the individual composites of the primary outcome	At 1 year.	All-cause mortality, non-fatal myocardial infarction, hospitalization with refractory angina, or hospitalization with heart failure.

Trial Locations

Locations (6)

Bispebjerg Hospital; 🇩🇰 Bispebjerg, Denmark

Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Zealand University Hospital; 🇩🇰 Copenhagen, Denmark

North Zealand Hospital; 🇩🇰 Hillerød, Denmark

Hvidovre Hospital; 🇩🇰 Hvidovre, Denmark

Herlev and Gentofte Hospital; 🇩🇰 Copenhagen, Hellerup, Denmark