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Coronary Artery Disease (CAD)BIOCORENCT07565805

Bern Intracoronary Optical Coherence Tomography and Coronary Computed Tomography Angiography Registry

An observational study of Coronary Artery Disease (CAD), run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Any age
Conditions the study is for
Coronary Artery Disease (CAD)
How many people
816 participants
Where
1 siteSwitzerland
Study dates
17 Oct 2025to 31 Dec 2033
How long will I take part?
5 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

  • ≥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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sarah Bär, MD, PhD contact

+41316322111

sarah.baer@insel.ch

Räber Lorenz, Prof. MD PhD contact

+41316322111

lorenz.raeber@insel.ch

Switzerland1 site, 1 recruiting

  • Department of Cardiology, Bern University Hospital Inselspital

    Bern, 3010

    Sarah Bär, MD-PhD, +41316322111, sarah.baer@insel.ch

    Lorenz Räber, Prof. MD-PhD, +41316322111, lorenz.raeber@insel.ch

    Recruiting

Other trials in Switzerland

About this study

Official title: 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.

Read the 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.

Keywords
Coronary artery disease (CAD), Optical coherence tomography (OCT), Coronary computed tomography angiography (CCTA)
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07565805
Study groupRoleWhat they receive
Patients undergoing paired CCTA and OCTPatients undergoing CCTA and invasive coronary angiography with OCT within 3 months

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Baseline

  2. PCI planning with CCTA vs. gold standard OCT

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

    Measured: Baseline

  3. 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)

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2026
  2. Study start17 Oct 2025
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
816 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT07565805
Sponsor's protocol ID
2025-01507
Other IDs
FF25040, 84802808, 2025
Acronym
BIOCORE
Status last verified
May 2026
First submitted
27 Apr 2026
Last updated
12 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data will be shared upon reasonable request from the principal investigator.

Publications

  • 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.

    PubMed 35368058

  • 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.

    PubMed 41460775

  • 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.

    PubMed 40243706

  • 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.

    PubMed 40630246

  • 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.

    PubMed 32174130

  • 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.

    PubMed 38849237

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease (CAD), run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sarah Bär, MD, PhD (+41316322111, sarah.baer@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diagnostic accuracy in plaque phenotyping CCTA vs. OCT (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07565805, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.

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