Multicentre Registry of CCTA, IVUS and OCT

NCT ID: NCT04066062

Last Updated: 2024-11-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 1700 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2025-12-31

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.

Conditions

Coronary Artery Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

Retrospective

A total of 700 vessel from 700 patients clinically indicated CCTA and IVUS or OCT performed within 3 months.

No interventions assigned to this group

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

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Toho University - Omori Medical Center

UNKNOWN

Sponsor Role: collaborator

Cleerly, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rine Nakanishi, MD

Role: PRINCIPAL_INVESTIGATOR

Toho University - Omori Medical Center

Locations

Ehime University

Ehime, , Japan

Hiroshima University

Hiroshima, , Japan

Yotsuba Circulation Clinic

Matsuyama, , Japan

Okayama Red Cross Hospital

Okayama, , Japan

Toho University Omori Medical Center

Tokyo, , Japan

Edogawa Hospital

Tokyo, , Japan

Juntendo University

Tokyo, , Japan

Sakakibara Heart Institute

Tokyo, , Japan

Tokai University

Tokyo, , Japan

Countries

Japan

References

Nakanishi R, Okubo R, Sobue Y, Kaneko U, Sato H, Fujimoto S, Nozaki Y, Kajiya T, Miyoshi T, Ichikawa K, Abe M, Kitagawa T, Ikenaga H, Osawa K, Saji M, Iguchi N, Nakazawa G, Takahashi K, Ijich T, Mikamo H, Kurata A, Moroi M, Iijima R, Malkasian S, Crabtree T, Chamie D, Alexandra LJ, Min JK, Earls JP, Matsuo H. Rationale and design of the INVICTUS Registry: (Multicenter Registry of Invasive and Non-Invasive imaging modalities to compare Coronary Computed Tomography Angiography, Intravascular Ultrasound and Optical Coherence Tomography for the determination of Severity, Volume and Type of coronary atherosclerosiS). J Cardiovasc Comput Tomogr. 2023 Nov-Dec;17(6):401-406. doi: 10.1016/j.jcct.2023.08.011. Epub 2023 Sep 9.

Reference Type: DERIVED

PMID: 37679247 (View on PubMed)

Other Identifiers

Invictus Registry

Identifier Type: -

Identifier Source: org_study_id