Coronary Artery Disease (CAD)
Conditions
Keywords
Coronary artery disease (CAD), Optical coherence tomography (OCT), Coronary computed tomography angiography (CCTA)
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.
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.
Interventions
None listed
Sponsors
Insel Gruppe AG, University Hospital Bern
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. ≥18 years of age 2. Written informed consent 3. CCTA within 3 months from invasive coronary angiography and OCT 4. At least one vessel with ≥50% diameter stenosis on CCTA 5. OCT performed in native coronary arteries (i.e. pre-PCI or no PCI)
Exclusion criteria
1. CCTA performed more than 3 months from OCT 2. Poor OCT quality 3. Poor CCTA quality 4. Coronary anomalies 5. Prior PCI or CABG in the vessel imaged with OCT
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic accuracy in plaque phenotyping CCTA vs. OCT | Baseline | 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) |
| PCI planning with CCTA vs. gold standard OCT | Baseline | Diagnostic accuracy of CCTA in identifying the need for PCI and agreement in stent sizing |
| Photon-counting vs. conventional CCTA | Baseline | 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) |
Countries
Switzerland
Contacts
CONTACTSarah Bär, MD, PhD
CONTACTRäber Lorenz, Prof. MD PhD
STUDY_CHAIRLorenz Räber, Prof. MD-PhD
Department of Cardiology, Bern University Hospital Inselspital, Switzerland
PRINCIPAL_INVESTIGATORSarah Bär, MD-PhD
Department of Cardiology, Bern University Hospital Inselspital, Switzerland
PRINCIPAL_INVESTIGATORChristoph Gräni, Prof. MD-PhD
Department of Cardiology, Bern University Hospital Inselspital, Switzerland
Outcome results
None listed