Bern Intracoronary Optical Coherence Tomography and Coronary Computed Tomography Angiography Registry

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorInsel Gruppe AG, University Hospital Bern

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥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

Disqualifiers

CCTA performed more than 3 months from OCT

Poor OCT quality

Poor CCTA quality

Coronary anomalies

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

816 Participants
are grouped into 1 trial group
Group A: Patients undergoing paired CCTA and OCT

Trial outcomes

Primary outcomes

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)

Time frame
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

Time frame
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)

Time frame
Baseline

Secondary outcomes

Other outcomes

1

Clinical outcomes throughout 1 and 5 years

* All-cause death * Cardiovascular death * Myocardial infarction * Unstable angina pectoris * Clinically-driven coronary revascularization * Stent thrombosis * In-stent-restenosis

Time frame
1 and 5 years follow-up

Sponsors and contacts

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