Clinical trial NCT04066062: Multicentre Registry of CCTA, IVUS and OCT
Official title: 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 type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Coronary Artery Disease
Keywords: CAD
Lead sponsor: Cleerly, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Toho University - Omori Medical Center
First posted: 2019-08-26
Enrollment: 1700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with single/multi vessel atherosclerotic coronary artery disease

Brief summary: The Invictus Registry will compare the diagnostic performance of coronary computed tomography angiography (CCTA) versus intravascular imaging by intravenous ultrasound (IVUS) or optical coherence tomography (OCT) for the measurement of minimum lumen area, the identification of stenosis severity, burden, morphology and vulnerability of coronary atherosclerosis.

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.

Eligibility criteria: 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

Primary outcomes:
measure: To compare the diagnostic performance of CCTA versus IVUS or OCT for the measurement of minimum lumen area.
timeFrame: June 2019- June 2021
Secondary outcomes:
Other outcomes:
Locations:
city: Ehime
country: Japan
facility: Ehime University
city: Hiroshima
country: Japan
facility: Hiroshima University
city: Matsuyama
country: Japan
facility: Yotsuba Circulation Clinic
city: Okayama
country: Japan
facility: Okayama Red Cross Hospital
city: Tokyo
country: Japan
facility: Toho University Omori Medical Center
city: Tokyo
country: Japan
facility: Edogawa Hospital
city: Tokyo
country: Japan
facility: Juntendo University
city: Tokyo
country: Japan
facility: Sakakibara Heart Institute
city: Tokyo
country: Japan
facility: Tokai University
Study officials:
affiliation: Toho University - Omori Medical Center
name: Rine Nakanishi, MD
role: PRINCIPAL_INVESTIGATOR
References: