Integrated Coronary Multicenter Imaging Registry

NCT ID: NCT03298282

Last Updated: 2020-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-10

Study Completion Date

2021-09-30

Brief Summary

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The coronary images of selective angiography and optical coherence tomography with FFR(Fractional Flow Reserve) values of the intermediate lesions (40-70% stenosis) will be prospectively registered.

Detailed Description

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The patients with intermediate lesions after CT angiography and invasive coronary angiography will be screened, and optical coherence tomography, FFR and selective CT angiography will be performed. The coronary images and FFR values will be registered, and the patients will be followed-up up to 2 years to investigate the adverse clinical events.

Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Imaging Registry

Imaging cohort: Patients with intermediate lesions

OCT (Optical Coherence Tomography)

Intervention Type OTHER

Coronary images by OCT and selective CTA and FFR values will be registered.

Coronary CTA

Intervention Type OTHER

Coronary images by OCT and Coronary CTA and FFR values will be registered.

FFR

Intervention Type OTHER

Coronary images by OCT and selective CTA and FFR values will be registered.

Interventions

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OCT (Optical Coherence Tomography)

Coronary images by OCT and selective CTA and FFR values will be registered.

Intervention Type OTHER

Coronary CTA

Coronary images by OCT and Coronary CTA and FFR values will be registered.

Intervention Type OTHER

FFR

Coronary images by OCT and selective CTA and FFR values will be registered.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients who underwent coronary CT angiography because of chest pain
* Patients who need OCT or FFR evaluation because of intermediate lesions according to invasive angiography (diameter stenosis of 40-70%)
* Age: 20-80 yrs
* Patients who consent and fully understand the protocol
* Patients who consent the clinical follow-up
* Patients who can be followed-up

Exclusion Criteria

* Patients who had contrast allergy
* Patients who had unstable blood pressure needing the vasopressors
* Patients who had severe left ventricular function (left ventricular ejection fraction\<30%)
* Chronic kidney disease who had Cr level of greater than 2.0 mg/dl
* Patients whose expected survival is less than 12 months
* Patients who had a severe valvular disease
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jung-Sun Kim, PhD

Role: PRINCIPAL_INVESTIGATOR

Severance Hospital

Locations

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Division of Cardiology, Cardiovascular Hospital, Yonsei University

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Lee YJ, Kim YW, Ha J, Kim M, Guagliumi G, Granada JF, Lee SG, Lee JJ, Cho YK, Yoon HJ, Lee JH, Kim U, Jang JY, Oh SJ, Lee SJ, Hong SJ, Ahn CM, Kim BK, Chang HJ, Ko YG, Choi D, Hong MK, Jang Y, Lee JS, Kim JS. Computational Fractional Flow Reserve From Coronary Computed Tomography Angiography-Optical Coherence Tomography Fusion Images in Assessing Functionally Significant Coronary Stenosis. Front Cardiovasc Med. 2022 Jun 13;9:925414. doi: 10.3389/fcvm.2022.925414. eCollection 2022.

Reference Type DERIVED
PMID: 35770218 (View on PubMed)

Other Identifiers

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1-2017-0049

Identifier Type: -

Identifier Source: org_study_id

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