Multicentre Registry of CCTA, IVUS and OCT
Registry of Coronary Computed Tomography Angiography Intravenous Ultrasound and Optical Coherence Tomography to Compare Invasive/Non-invasive Imaging Modalities for Determination of Severity Volume and Type of Coronary Atherosclerosis
Study Overview
Status
Conditions
Detailed Description
Clinical Significance:
Coronary computed tomographic angiography (CCTA) is a robust non-invasive modality to evaluate the presence, extent and severity of Coronary Artery Disease (CAD). For a plaque assessment, previous studies demonstrated that CCTA provides a high correlation with intravascular imaging by intravenous ultrasound (IVUS) in assessing coronary plaque characteristics stenosis severity and volume. High risk (vulnerable) plaque characteristics (positive remodeling, low attenuation plaque, spotty calcifications) are recognized to be more prone to rupture with increased rates of short-term cardiovascular disease events. Although several studies similarly demonstrated the good concordance between CCTA and IVUS or optical coherence tomography (OCT) in assessing high risk plaque features, patient numbers in these prior studies were limited to fully understand the effect of CCTA for the assessment of coronary atherosclerotic plaque features.
The Research is a multi-center, registry enrolling patients with single/multi vessel atherosclerotic coronary artery disease. The study will be conducted in up to 15 Medical Centers in Japan. In each patient, a CCTA, IVUS), and/ or OCT will be performed, to provide a total of 1,300 vessels from 1,000 patients. Thus, the full cohort (Prospective plus Retrospective patients) will provide a total of 2,000 vessels as basis for a diagnostic performance comparison between CCTA and IVUS or OCT. Accrual is expected to take 24 months.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Ehime, Japan
- Ehime University
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Hiroshima, Japan
- Hiroshima University
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Matsuyama, Japan
- Yotsuba Circulation Clinic
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Okayama, Japan
- Okayama Red Cross Hospital
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Tokyo, Japan
- Juntendo University
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Tokyo, Japan, 143-8540
- Toho University Omori Medical Center
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Tokyo, Japan
- Edogawa Hospital
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Tokyo, Japan
- Sakakibara Heart Institute
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Tokyo, Japan
- Tokai University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Signed informed consent, inclusive of release of medical information, and Health Insurance Portability and Accountability Act (HIPAA) documentation
- Age 18 years or older
- Known or suspected Coronary Artery Disease and subsequently indicated for coronary artery angiography
Exclusion Criteria:
- Individuals unable to provide informed consent
- Acute ST elevation myocardial infarction
- Pregnant woman
- Angiographically visible thrombus at the site of the lesion interrogated by IVUS or OCT
- Patients with lesions required balloon angioplasty before OCT and/or IVUS
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
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Retrospective
A total of 700 vessel from 700 patients clinically indicated CCTA and IVUS or OCT performed within 3 months.
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Prospective
A total of 1,000 subjects will be enrolled in this Registry.
This number of subject is expected to provide a maximum of 1,300 vessels.
All CCTA and IVUS/OCT will be performed within 3 months
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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To compare the diagnostic performance of CCTA versus IVUS or OCT for the measurement of minimum lumen area.
Time Frame: June 2019- June 2021
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Patients will undergo invasive coronary angiography with IVUS/OCT for the measurement of minimum lumen area, the identification of stenosis severity, burden, morphology and vulnerability of coronary atherosclerosis. The co-registration of IVUS/OCT images with CCTA segmented images will be implemented in the following three stages by locating the corresponding anatomical landmarks/fiduciary points (coronary ostia, side-branches, calcified plaques, and/or overlapping veins) and matching the corresponding coronary segments in all the imaging modalities |
June 2019- June 2021
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Rine Nakanishi, MD, Toho University - Omori Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Invictus Registry
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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