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| Name | Class |
|---|---|
| Toho University - Omori Medical Center | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retrospective | A total of 700 vessel from 700 patients clinically indicated CCTA and IVUS or OCT performed within 3 months. | ||
| 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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| Measure | Description | Time Frame |
|---|---|---|
| To compare the diagnostic performance of CCTA versus IVUS or OCT for the measurement of minimum lumen area. | 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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Inclusion Criteria:
Exclusion Criteria:
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Patients with single/multi vessel atherosclerotic coronary artery disease
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| Name | Affiliation | Role |
|---|---|---|
| Rine Nakanishi, MD | Toho University - Omori Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ehime University | Ehime | Japan | ||||
| Hiroshima University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41781729 | Derived | Nakanishi R, Okubo R, Matsuo H, 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, Ijichi T, Mikamo H, Kurata A, Moroi M, Iijima R, Bandeira D, Demuyakor A, Parise H, Malkasian S, Mintz GS, Lansky AJ, Earls JP, Chamie D. Artificial intelligence-based coronary computed tomography angiography quantification of atherosclerosis burden: comparison with intravascular ultrasound in the INVICTUS Registry. Eur Radiol. 2026 Jul;36(7):5364-5377. doi: 10.1007/s00330-026-12412-y. Epub 2026 Mar 5. | |
| 37679247 |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Hiroshima |
| Japan |
| Yotsuba Circulation Clinic | Matsuyama | Japan |
| Okayama Red Cross Hospital | Okayama | Japan |
| Toho University Omori Medical Center | Tokyo | 143-8540 | Japan |
| Edogawa Hospital | Tokyo | Japan |
| Juntendo University | Tokyo | Japan |
| Sakakibara Heart Institute | Tokyo | Japan |
| Tokai University | Tokyo | Japan |
| Derived |
| 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. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |