Bern Intracoronary Optical Coherence Tomography and Coronary Computed Tomography Angiography Registry (BIOCORE)
7. mai 2026 oppdatert av: Insel Gruppe AG, University Hospital Bern
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.
Studieoversikt
Status
Rekruttering
Forhold
Detaljert beskrivelse
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.
Studietype
Observasjonsmessig
Registrering (Antatt)
816
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Sarah Bär, MD, PhD
- Telefonnummer: +41316322111
- E-post: sarah.baer@insel.ch
Studer Kontakt Backup
- Navn: Räber Lorenz, Prof. MD PhD
- Telefonnummer: +41316322111
- E-post: lorenz.raeber@insel.ch
Studiesteder
-
-
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Bern, Sveits, 3010
- Rekruttering
- Department of Cardiology, Bern University Hospital Inselspital
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Ta kontakt med:
- Sarah Bär, MD-PhD
- Telefonnummer: +41316322111
- E-post: sarah.baer@insel.ch
-
Ta kontakt med:
- Lorenz Räber, Prof. MD-PhD
- Telefonnummer: +41316322111
- E-post: lorenz.raeber@insel.ch
-
Hovedetterforsker:
- Lorenz Räber, Prof. MD-PhD
-
Underetterforsker:
- Sarah Bär, MD-PhD
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Underetterforsker:
- Christoph Gräni, Prof. MD-PhD
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Patients undergoing CCTA and invasive coronary angiography with OCT in native coronary vessels within 3 months
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
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Patients undergoing paired CCTA and OCT
Patients undergoing CCTA and invasive coronary angiography with OCT within 3 months
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Diagnostic accuracy in plaque phenotyping CCTA vs. OCT
Tidsramme: Baseline
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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
|
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PCI planning with CCTA vs. gold standard OCT
Tidsramme: Baseline
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Diagnostic accuracy of CCTA in identifying the need for PCI and agreement in stent sizing
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Baseline
|
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Photon-counting vs. conventional CCTA
Tidsramme: Baseline
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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)
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Baseline
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Clinical outcomes throughout 1 and 5 years
Tidsramme: 1 and 5 years follow-up
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1 and 5 years follow-up
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Studiestol: Lorenz Räber, Prof. MD-PhD, Department of Cardiology, Bern University Hospital Inselspital, Switzerland
- Hovedetterforsker: Sarah Bär, MD-PhD, Department of Cardiology, Bern University Hospital Inselspital, Switzerland
- Hovedetterforsker: Christoph Gräni, Prof. MD-PhD, Department of Cardiology, Bern University Hospital Inselspital, Switzerland
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
17. oktober 2025
Primær fullføring (Antatt)
31. desember 2028
Studiet fullført (Antatt)
31. desember 2033
Datoer for studieregistrering
Først innsendt
27. april 2026
Først innsendt som oppfylte QC-kriteriene
27. april 2026
Først lagt ut (Faktiske)
4. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
12. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
7. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2025-01507
- FF25040 (Annet stipend/finansieringsnummer: Swiss Heart Foundation)
- 84802808 (Annet stipend/finansieringsnummer: Young Investigator Grant Department of Clinical Research, University of Bern)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
Data will be shared upon reasonable request from the principal investigator.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .