Paired intracoronary OCT and coronary CT angiography to map plaque and blockages
Bern Intarcoronary Optical Coherence Tomography and Coronary Computed Tomography Angiography Registry
This project will test whether advanced coronary CT scans can provide the same detailed plaque and blockage information as invasive intracoronary optical coherence tomography (OCT) in adults with coronary artery disease who have both scans.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 816 (estimated) |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Bern) |
| Trial ID | NCT07565805 on ClinicalTrials.gov |
What this trial studies
BIOCORE is a systematic registry at Bern University Hospital enrolling adults with coronary artery disease who undergo both coronary computed tomography angiography (CCTA) and intracoronary optical coherence tomography (OCT). The registry requires CCTA within three months of invasive coronary angiography and OCT, and at least one vessel with ≥50% diameter stenosis on CCTA, with OCT performed in native arteries before any PCI. The project compares advanced CCTA techniques (including photon-counting CT and AI-driven analyses) against OCT as the invasive gold standard for plaque morphology, lesion severity, and PCI guidance. Imaging features will be linked to long-term clinical outcomes to improve noninvasive diagnosis and treatment planning.
Who should consider this trial
Good fit: Adults (≥18 years) who give written consent, have a CCTA within three months of invasive coronary angiography and OCT, have at least one vessel with ≥50% stenosis on CCTA, and have OCT performed in native coronary arteries (pre-PCI or no PCI).
Not a fit: Patients with prior PCI or CABG in the vessel imaged, coronary anomalies, or poor-quality OCT or CCTA images are unlikely to receive useful matched imaging information from this registry.
Why it matters
Potential benefit: If successful, this work could allow noninvasive CCTA (with newer hardware and AI tools) to reliably characterize plaque and help guide treatment decisions that today often require invasive imaging.
How similar studies have performed: While improvements in CCTA technology and AI analyses are promising, direct paired comparisons with OCT are limited, so this paired-registry approach is relatively novel though grounded in existing imaging research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. ≥18 years of age 2. Written informed consent 3. CCTA within 3 months from invasive coronary angiography and OCT 4. At least one vessel with ≥50% diameter stenosis on CCTA 5. OCT performed in native coronary arteries (i.e. pre-PCI or no PCI) Exclusion Criteria: 1. CCTA performed more than 3 months from OCT 2. Poor OCT quality 3. Poor CCTA quality 4. Coronary anomalies 5. Prior PCI or CABG in the vessel imaged with OCT
Where this trial is running
Bern
- Department of Cardiology, Bern University Hospital Inselspital — Bern, Switzerland (Recruiting)
Study contacts
- Principal investigator: Sarah Bär, MD-PhD — Department of Cardiology, Bern University Hospital Inselspital, Switzerland
- Study coordinator: Sarah Bär, MD, PhD
- Email: sarah.baer@insel.ch
- Phone: +41316322111
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.