An observational study in Coronary Artery Disease (CAD), sponsored by Insel Gruppe AG, University Hospital Bern. Recruiting at 1 site in Switzerland. Per ClinicalTrials.gov, last updated 2026-05-12.
Sponsored by Insel Gruppe AG, University Hospital Bern · Observational
Bern Intracoronary Optical Coherence Tomography and Coronary Computed Tomography Angiography Registry (BIOCORE) is a systematic institutional registry on patients undergoing paired CCTA and OCT for validation and development of advanced methods to determine coronary plaque morphology, lesion severity, PCI guidance, and it association with long-term clinical outcomes.
Intracoronary imaging represents the current gold standard for in-vivo assessment of plaque morphology and guidance of percutaneous coronary intervention (PCI). However, coronary computed tomography angiography (CCTA) plays an increasingly important role in the diagnostic pathway of CAD and represents a non-invasive procedure with wide availability, relatively low costs, and low radiation dose. Owing to its recent technical advances with the introduction of photon-counting CT with higher spatial resolution and diagnostic accuracy as compared to conventional CCTA, as well as recently developed artificial intelligence (AI)-guided analysis softwares, CCTA has the potential to provide more and more clinically essential information about coronary artery disease (CAD) with respect to plaque composition, lesion severity, need for intervention, and periprocedural planning that has traditionally been restricted to invasive coronary angiography and intracoronary imaging. Therefore, there is a timely need for systematic evaluation of advanced CCTA techniques against invasive gold standards. Furthermore, studies comparing CCTA to optical coherence tomography (OCT), the gold standard for plaque phenotyping, are scarce to date. Also, traditional treatment concepts of CAD that are based on obstructive stenosis and ischemia are currently challenged by an increasing body of evidence demonstrating the prognostic impact of plaque burden and composition independent of flow-limitation. Plaque burden and composition may emerge as the next treatment target in CAD. Therefore, the investigators established a systematic institutional registry on patients undergoing paired CCTA and OCT for validation and development of advanced methods to determine coronary plaque morphology, lesion severity, PCI guidance, and it association with long-term clinical outcomes.
5,596 studies on the registry are indexed under Coronary Artery Disease; 955 are open to participants now.
This study's planned enrollment of 816 is above the median of 336 across 1,946 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Insel Gruppe AG, University Hospital Bern is the lead sponsor of 724 studies on the registry; 177 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients undergoing CCTA and invasive coronary angiography with OCT in native coronary vessels within 3 months
Exclusion Criteria:
Patients undergoing CCTA and invasive coronary angiography with OCT within 3 months
Diagnostic accuracy in plaque phenotyping CCTA vs. OCT
Proportion of correctly classified plaques quantitative computed tomography (QCT) (low-attenuation, non-calcified, calcified plaques) against the gold standard OCT (lipid-rich, fibrous, fibro-calcific plaque)
Time frame: Baseline
PCI planning with CCTA vs. gold standard OCT
Diagnostic accuracy of CCTA in identifying the need for PCI and agreement in stent sizing
Time frame: Baseline
Photon-counting vs. conventional CCTA
Proportion of correctly classified plaques with photon-counting CCTA vs. conventional CCTA (low-attenuation, non-calcified, calcified plaques) against the gold standard OCT for plaque morphology (lipid-rich, fibrous, fibro-calcific plaque)
Time frame: Baseline
Clinical outcomes throughout 1 and 5 years
* All-cause death * Cardiovascular death * Myocardial infarction * Unstable angina pectoris * Clinically-driven coronary revascularization * Stent thrombosis * In-stent-restenosis
Time frame: 1 and 5 years follow-up
Plan to share: No — Data will be shared upon reasonable request from the principal investigator.
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Insel Gruppe AG, University Hospital Bern