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

Rigshospitalet, Denmark2,300 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

2,300

Conditions

Ischemic Heart Disease Non STEMI Angina Pectoris, Unstable Coronary Disease

Interventions

CCTAPROCEDURE

Participants will be examined with CCTA during admission.

Conventional ICAPROCEDURE

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

Team-based interventional triageOTHER

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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 \< 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

Locations (6)

Herlev and Gentofte Hospital

Copenhagen, Hellerup, Denmark

RECRUITING

Bispebjerg Hospital

Bispebjerg, Denmark

RECRUITING

Rigshospitalet

Copenhagen, Denmark

RECRUITING

Zealand University Hospital

Copenhagen, Denmark

RECRUITING

North Zealand Hospital

Hillerød, Denmark

RECRUITING

Hvidovre Hospital

Hvidovre, Denmark

RECRUITING

Outcomes

Primary Outcomes

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

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.

Number of participants with cardiovascular death

Time frame: At 1 year.

Number of participants with unplanned coronary revascularization

Time frame: At 1 year.

Health-related Quality of life

Measured by EQ-5D-5L

Time frame: At 1 year.

Angina symptom burden

Measured by Seattle Angina Questionnaire

Time frame: At 1 year.

Total (cumulative) radiation dosage during index admission

Time frame: At 1st hospital discharge, an average of 2 days.

Length of index hospitalization

Time frame: At 1st hospital discharge, an average of 2 days.

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

Overview

Conditions

Interventions

Eligibility

Locations (6)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts