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NCT Number: NCT07565805

Bern Intracoronary 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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Cardiology, Bern University Hospital Inselspital

Bern, 3010, Switzerland

Location status: Recruiting

Location contact

Christoph Gräni, Prof. MD-PhD

SUB_INVESTIGATOR

Lorenz Räber, Prof. MD-PhD

CONTACT

[email protected]

+41316322111

Lorenz Räber, Prof. MD-PhD

PRINCIPAL_INVESTIGATOR

Sarah Bär, MD-PhD

CONTACT

[email protected]

+41316322111

Sarah Bär, MD-PhD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥18 years of age
  • Written informed consent
  • CCTA within 3 months from invasive coronary angiography and OCT
  • At least one vessel with ≥50% diameter stenosis on CCTA
  • OCT performed in native coronary arteries (i.e. pre-PCI or no PCI)

Exclusion criteria

  • CCTA performed more than 3 months from OCT
  • Poor OCT quality
  • Poor CCTA quality
  • Coronary anomalies
  • Prior PCI or CABG in the vessel imaged with OCT

Treatment and study plan

Primary outcomes

  1. 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)

  2. 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

  3. 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)

Other outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Räber Lorenz, Prof. MD PhD

CONTACT

[email protected]

+41316322111

Sarah Bär, MD, PhD

CONTACT

[email protected]

+41316322111

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

Bern Intarcoronary Optical Coherence Tomography and Coronary Computed Tomography Angiography Registry

Acronym: BIOCORE

Important dates

Study start
2025
Primary completion
2028
Study completion
2033
First posted
May 4, 2026
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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