Actively Recruiting

All Genders
ID07565805

Bern Intracoronary Optical Coherence Tomography and Coronary Computed Tomography Angiography Registry

Led by Insel Gruppe AG, University Hospital Bern · Updated on 2026-05-12

816

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are conducting the Bern Intracoronary Optical Coherence Tomography and Coronary Computed Tomography Angiography Registry (BIOCORE) to study coronary artery disease (CAD). The registry focuses on patients undergoing both coronary computed tomography angiography (CCTA) and optical coherence tomography (OCT) to validate and develop advanced methods for assessing coronary plaque characteristics, lesion severity, and guidance for percutaneous coronary intervention (PCI). This research aims to better understand the relationship between plaque features and long-term clinical outcomes. Participants in this observational study will undergo paired CCTA and OCT imaging within 3 months. The study compares the diagnostic accuracy of new photon-counting CT technology and AI-guided CCTA analysis against the current gold standard, invasive OCT. Patients included have at least one vessel with 50% or greater stenosis on CCTA and OCT imaging is performed on native coronary arteries before any PCI. During the study, researchers will review imaging results to evaluate plaque phenotyping, lesion severity, and PCI planning accuracy. The main outcomes include comparing CCTA with OCT and assessing photon-counting versus conventional CCTA. Participants will be monitored based on their imaging data, with no additional interventions. The study helps advance non-invasive diagnostic methods and may influence future CAD treatment planning.

CONDITIONS

Brief Title

Bern Intracoronary Optical Coherence Tomography and Coronary Computed Tomography Angiography Registry

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years of age or older
  • Written informed consent provided
  • Coronary computed tomography angiography (CCTA) performed within 3 months of invasive coronary angiography and OCT
  • At least one vessel with 50% or greater diameter narrowing on CCTA
  • Optical coherence tomography (OCT) performed in native coronary arteries before any PCI
Not Eligible

You will not qualify if you...

  • CCTA performed more than 3 months before OCT
  • Poor quality OCT images
  • Poor quality CCTA images
  • Presence of coronary artery anomalies
  • Prior percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) in the vessel examined with OCT

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 3 months

Participants undergo coronary computed tomography angiography (CCTA) and invasive coronary angiography with optical coherence tomography (OCT) to assess coronary plaque morphology and lesion severity.

1 to 2 visits depending on imaging procedures

Long-term Monitoring

Duration - Up to several years until study completion

Participants are observed for long-term clinical outcomes related to coronary artery disease after imaging procedures.

Visits as per routine clinical follow-up

Trial Site Locations

Total: 1 location

1

Department of Cardiology, Bern University Hospital Inselspital

Bern, Switzerland, 3010

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Research Team

S

Sarah Bär, MD, PhD

R

Räber Lorenz, Prof. MD PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Frequently Asked Questions

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Published Research Related To This Trial

Effect of Alirocumab Added to High-Intensity Statin Therapy on Coronary Atherosclerosis in Patients With Acute Myocardial Infarction: The PACMAN-AMI Randomized Clinical Trial.

Lorenz Räber, Yasushi Ueki, Tatsuhiko Otsuka...

https://pubmed.ncbi.nlm.nih.gov/35368058

Outcomes with revascularization vs. medical therapy according to plaque burden from coronary computed tomography angiography.

Sarah Bär, Juhani Knuuti, Antti Saraste...

https://pubmed.ncbi.nlm.nih.gov/41460775

Derivation and validation of an artificial intelligence-based plaque burden safety cut-off for long-term acute coronary syndrome from coronary computed tomography angiography.

Sarah Bär, Juhani Knuuti, Antti Saraste...

https://pubmed.ncbi.nlm.nih.gov/40243706

Coronary Computed Tomography Angiography to Guide Percutaneous Coronary Intervention: Expert Opinion from a SCAI/SCCT Roundtable.

Yader Sandoval, Jonathon A Leipsic, Carlos Collet...

https://pubmed.ncbi.nlm.nih.gov/40630246

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).

Michelle C Williams, Jacek Kwiecinski, Mhairi Doris...

https://pubmed.ncbi.nlm.nih.gov/32174130

Standards for quantitative assessments by coronary computed tomography angiography (CCTA): An expert consensus document of the society of cardiovascular computed tomography (SCCT).

Koen Nieman, Hector M García-García, Alexandre Hideo-Kajita...

https://pubmed.ncbi.nlm.nih.gov/38849237