NCT04066062

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2019

Longer than P75 for all trials

Geographic Reach
1 country

9 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 26, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

November 26, 2024

Status Verified

November 1, 2024

Enrollment Period

3.3 years

First QC Date

August 15, 2019

Last Update Submit

November 25, 2024

Conditions

Coronary Artery Disease

Keywords

CAD

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with single/multi vessel atherosclerotic coronary artery disease

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Ehime University

Ehime, Japan

Location

Hiroshima University

Hiroshima, Japan

Location

Yotsuba Circulation Clinic

Matsuyama, Japan

Location

Okayama Red Cross Hospital

Okayama, Japan

Location

Toho University Omori Medical Center

Tokyo, 143-8540, Japan

Location

Edogawa Hospital

Tokyo, Japan

Location

Juntendo University

Tokyo, Japan

Location

Sakakibara Heart Institute

Tokyo, Japan

Location

Tokai University

Tokyo, Japan

Location

Related Publications (1)

  • 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.

    PMID: 37679247DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Rine Nakanishi, MD

    Toho University - Omori Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
2 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2019

First Posted

August 26, 2019

Study Start

October 1, 2019

Primary Completion

December 31, 2022

Study Completion

December 31, 2025

Last Updated

November 26, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

JP(9)