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| ID | Type | Description | Link |
|---|---|---|---|
| FF25040 | Other Grant/Funding Number | Swiss Heart Foundation | |
| 84802808 | Other Grant/Funding Number | Young Investigator Grant Department of Clinical Research, University of Bern |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients undergoing paired CCTA and OCT | Patients undergoing CCTA and invasive coronary angiography with OCT within 3 months |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Clinical outcomes throughout 1 and 5 years |
| 1 and 5 years follow-up |
Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing CCTA and invasive coronary angiography with OCT in native coronary vessels within 3 months
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah Bär, MD, PhD | Contact | +41316322111 | sarah.baer@insel.ch | |
| Räber Lorenz, Prof. MD PhD | Contact | +41316322111 | lorenz.raeber@insel.ch |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiology, Bern University Hospital Inselspital | Recruiting | Bern | 3010 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35368058 | Background | 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. | |
| 41460775 |
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Data will be shared upon reasonable request from the principal investigator.
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Christoph Gräni, Prof. MD-PhD | Department of Cardiology, Bern University Hospital Inselspital, Switzerland | Principal Investigator |
| 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. |
| 40243706 | 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. |
| 40630246 | 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. |
| 32174130 | 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. |
| 38849237 | 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. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |