Comparing two methods for diagnosing heart conditions in patients with non-ST elevation acute coronary syndrome
Team-based Interventional Triage in Acute Coronary Syndrome Based on Non-Invasive Computed Tomography Coronary Angiography - a Randomized Trial
This study is testing if a non-invasive heart scan can safely and effectively diagnose heart conditions in patients with certain types of heart attacks, compared to the traditional invasive method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2300 (estimated) |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Locations | 6 sites (Copenhagen, Hellerup and 5 other locations) |
| Trial ID | NCT06101862 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of coronary computed tomography angiography (CCTA) compared to invasive coronary angiography (ICA) in patients diagnosed with non-ST-segment elevation myocardial infarction (NSTEACS). It aims to determine if CCTA can serve as a safer and more efficient alternative to ICA, which is traditionally used in acute settings. The trial will involve patients who meet specific criteria, including those with elevated troponin levels or ischemic changes on their electrocardiograms. By assessing the outcomes of both diagnostic methods, the study seeks to provide evidence that could influence clinical practice in acute coronary syndrome management.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals admitted with non-ST-segment elevation myocardial infarction or unstable angina who require subacute invasive coronary angiography.
Not a fit: Patients who are unstable and require immediate invasive coronary angiography or those with severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a safer and more comfortable diagnostic approach for patients with acute coronary syndrome, reducing complications and healthcare costs.
How similar studies have performed: While CCTA is widely accepted for chronic conditions, this study is novel as it specifically investigates its use in the acute setting for NSTEACS, with limited prior large-scale randomized trials available.
Eligibility criteria
Show full inclusion / exclusion 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 \< 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
Where this trial is running
Copenhagen, Hellerup and 5 other locations
- 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)
Study contacts
- Study coordinator: Niels Thue Olsen, PhD
- Email: niels.thue.olsen@regionh.dk
- Phone: +45 38 68 38 68
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.