Bern Intracoronary Optical Coherence Tomography and Coronary Computed Tomography Angiography Registry (BIOCORE)

May 7, 2026 updated by: Insel Gruppe AG, University Hospital Bern

Bern Intarcoronary Optical Coherence Tomography and Coronary Computed Tomography Angiography Registry

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

816

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • Recruiting
        • Department of Cardiology, Bern University Hospital Inselspital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lorenz Räber, Prof. MD-PhD
        • Sub-Investigator:
          • Sarah Bär, MD-PhD
        • Sub-Investigator:
          • Christoph Gräni, Prof. MD-PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing CCTA and invasive coronary angiography with OCT in native coronary vessels within 3 months

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients undergoing paired CCTA and OCT
Patients undergoing CCTA and invasive coronary angiography with OCT within 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy in plaque phenotyping CCTA vs. OCT
Time Frame: Baseline
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)
Baseline
PCI planning with CCTA vs. gold standard OCT
Time Frame: Baseline
Diagnostic accuracy of CCTA in identifying the need for PCI and agreement in stent sizing
Baseline
Photon-counting vs. conventional CCTA
Time Frame: Baseline
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)
Baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical outcomes throughout 1 and 5 years
Time Frame: 1 and 5 years follow-up
  • All-cause death
  • Cardiovascular death
  • Myocardial infarction
  • Unstable angina pectoris
  • Clinically-driven coronary revascularization
  • Stent thrombosis
  • In-stent-restenosis
1 and 5 years follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Insel Gruppe AG, University Hospital Bern

Investigators

  • Study Chair: Lorenz Räber, Prof. MD-PhD, Department of Cardiology, Bern University Hospital Inselspital, Switzerland
  • Principal Investigator: Sarah Bär, MD-PhD, Department of Cardiology, Bern University Hospital Inselspital, Switzerland
  • Principal Investigator: Christoph Gräni, Prof. MD-PhD, Department of Cardiology, Bern University Hospital Inselspital, Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 17, 2025

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2033

Study Registration Dates

First Submitted

April 27, 2026

First Submitted That Met QC Criteria

April 27, 2026

First Posted (Actual)

May 4, 2026

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-01507
  • FF25040 (Other Grant/Funding Number: Swiss Heart Foundation)
  • 84802808 (Other Grant/Funding Number: Young Investigator Grant Department of Clinical Research, University of Bern)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be shared upon reasonable request from the principal investigator.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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