Bern Intracoronary Optical Coherence Tomography and Coronary Computed Tomography Angiography Registry

NCT07565805 | Recruiting DMC

• 3 other identifiers: 2025-01507FF2504084802808
• Study Type: observational
• Target: 816
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease (CAD); Optical Coherence Tomography (OCT); Coronary Computed Tomography Angiography (CCTA)

Keywords

coronary artery disease; optical coherence tomography; coronary computed tomography angiography

Outcome Measures

Primary Outcomes (3)

• 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)

  Baseline

• PCI planning with CCTA vs. gold standard OCT

  Diagnostic accuracy of CCTA in identifying the need for PCI and agreement in stent sizing

  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)

  Baseline

Other Outcomes (1)

• Clinical outcomes throughout 1 and 5 years

  1 and 5 years follow-up

Study Arms (1)

Patients undergoing paired CCTA and OCT

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• ≥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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Department of Cardiology, Bern University Hospital Inselspital

Bern, 3010, Switzerland

RECRUITING

Related Publications (6)

• Raber L, Ueki Y, Otsuka T, Losdat S, Haner JD, Lonborg J, Fahrni G, Iglesias JF, van Geuns RJ, Ondracek AS, Radu Juul Jensen MD, Zanchin C, Stortecky S, Spirk D, Siontis GCM, Saleh L, Matter CM, Daemen J, Mach F, Heg D, Windecker S, Engstrom T, Lang IM, Koskinas KC; PACMAN-AMI collaborators. Effect of Alirocumab Added to High-Intensity Statin Therapy on Coronary Atherosclerosis in Patients With Acute Myocardial Infarction: The PACMAN-AMI Randomized Clinical Trial. JAMA. 2022 May 10;327(18):1771-1781. doi: 10.1001/jama.2022.5218.

  PMID: 35368058 BACKGROUND

• Bar S, Knuuti J, Saraste A, Nurmohamed NS, Jukema RA, Klen R, Bax JJ, Knaapen P, Danad I, Maaniitty T. Outcomes with revascularization vs. medical therapy according to plaque burden from coronary computed tomography angiography. Eur Heart J Cardiovasc Imaging. 2026 Feb 27;27(3):554-566. doi: 10.1093/ehjci/jeaf372.

  PMID: 41460775 BACKGROUND

• Bar S, Knuuti J, Saraste A, Klen R, Kero T, Nabeta T, Bax JJ, Danad I, Nurmohamed NS, Jukema RA, Knaapen P, Maaniitty T. Derivation and validation of an artificial intelligence-based plaque burden safety cut-off for long-term acute coronary syndrome from coronary computed tomography angiography. Eur Heart J Cardiovasc Imaging. 2025 Jun 30;26(7):1163-1173. doi: 10.1093/ehjci/jeaf121.

  PMID: 40243706 BACKGROUND

• Sandoval Y, Leipsic JA, Collet C, Ali ZA, Azzalini L, Barbato E, Cavalcante JL, Costa RA, Garcia-Garcia HM, Jones DA, Khoo JK, Maran A, Nieman K, Pinilla-Echeverri N, Seto AH, Shlofmitz E, Brilakis ES. Coronary Computed Tomography Angiography to Guide Percutaneous Coronary Intervention: Expert Opinion from a SCAI/SCCT Roundtable. J Soc Cardiovasc Angiogr Interv. 2025 May 1;4(6):103664. doi: 10.1016/j.jscai.2025.103664. eCollection 2025 Jun.

  PMID: 40630246 BACKGROUND

• Williams MC, Kwiecinski J, Doris M, McElhinney P, D'Souza MS, Cadet S, Adamson PD, Moss AJ, Alam S, Hunter A, Shah ASV, Mills NL, Pawade T, Wang C, Weir McCall J, Bonnici-Mallia M, Murrills C, Roditi G, van Beek EJR, Shaw LJ, Nicol ED, Berman DS, Slomka PJ, Newby DE, Dweck MR, Dey D. Low-Attenuation Noncalcified Plaque on Coronary Computed Tomography Angiography Predicts Myocardial Infarction: Results From the Multicenter SCOT-HEART Trial (Scottish Computed Tomography of the HEART). Circulation. 2020 May 5;141(18):1452-1462. doi: 10.1161/CIRCULATIONAHA.119.044720. Epub 2020 Mar 16.

  PMID: 32174130 BACKGROUND

• Nieman K, Garcia-Garcia HM, Hideo-Kajita A, Collet C, Dey D, Pugliese F, Weissman G, Tijssen JGP, Leipsic J, Opolski MP, Ferencik M, Lu MT, Williams MC, Bruining N, Blanco PJ, Maurovich-Horvat P, Achenbach S. Standards for quantitative assessments by coronary computed tomography angiography (CCTA): An expert consensus document of the society of cardiovascular computed tomography (SCCT). J Cardiovasc Comput Tomogr. 2024 Sep-Oct;18(5):429-443. doi: 10.1016/j.jcct.2024.05.232. Epub 2024 Jun 6.

  PMID: 38849237 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Lorenz Räber, Prof. MD-PhD

  Department of Cardiology, Bern University Hospital Inselspital, Switzerland

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Bär, MD, PhD

CONTACT

+41316322111; sarah.baer@insel.ch

Räber Lorenz, Prof. MD PhD

CONTACT

+41316322111; lorenz.raeber@insel.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 4, 2026
• Study Start: October 17, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2033
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)