CT Coronary Angiography and Computational Fluid Dynamics

NCT ID: NCT01189331

Last Updated: 2021-03-16

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

COMPLETED

Clinical Phase

NA

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-13

Study Completion Date

2020-12-31

Brief Summary

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Angiographically obtained fractional flow reserve(FFR) could provide functional and clinical information about stenotic lesion, but the invasiveness and measuring difficulty of FFR make it unfamiliar to perform. CT coronary angiography is non-invasive tool to evaluate lesion severity and lately developing computational fluid dynamics could provide functional information. The investigators build a patient specific model of computational fluid dynamics by CT coronary angiography and evaluate the functional significance by measuring fractional flow reserve via CT coronary angiography and computational fluid dynamics, and investigate its long-term prognostic implications.

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators
With masking value of FFR derived from coronary CT angiography to the investigators, FFR is measured and patients have been followed-up.

Study Groups

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CT and FFR

Group Type NO_INTERVENTION

CT coronary angiography and computational fluid dynamics

Intervention Type DEVICE

Evaluate coronary blood flow dynamics by CT coronary angiography and computational fluid dynamics

Interventions

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CT coronary angiography and computational fluid dynamics

Evaluate coronary blood flow dynamics by CT coronary angiography and computational fluid dynamics

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Significant stenosis at CT angiography
* Normal ejection fraction on echocardiography
* Informed consented patient

Exclusion Criteria

* total occlusion and collateral flow to target vessel
* AV conduction abnormality
* Left ventricular hypertrophy
* significant valvular heart or primary myocardial disease
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Inje University

OTHER

Sponsor Role collaborator

Pauls Stradins Clinical University Hospital

OTHER

Sponsor Role collaborator

Cornell University

OTHER

Sponsor Role collaborator

Ulsan university

UNKNOWN

Sponsor Role collaborator

Indiana University

OTHER

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Bon-Kwon Koo

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bon-Kwon Koo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Yang S, Chung J, Lesina K, Doh JH, Jegere S, Erglis A, Leipsic JA, Fearon WF, Narula J, Koo BK. Long-term prognostic implications of CT angiography-derived fractional flow reserve: Results from the DISCOVER-FLOW study. J Cardiovasc Comput Tomogr. 2024 May-Jun;18(3):251-258. doi: 10.1016/j.jcct.2024.01.016. Epub 2024 Feb 19.

Reference Type DERIVED
PMID: 38378313 (View on PubMed)

Yang S, Lesina K, Doh JH, Jegere S, Erglis A, Leipsic JA, Chun EJ, Choi G, Schaap M, Zarins C, Taylor CA, Fearon WF, Narula J, Koo BK. Long-term prognostic implications of hemodynamic and plaque assessment using coronary CT angiography. Atherosclerosis. 2023 May;373:58-65. doi: 10.1016/j.atherosclerosis.2023.02.005. Epub 2023 Feb 27.

Reference Type DERIVED
PMID: 36872186 (View on PubMed)

Koo BK, Erglis A, Doh JH, Daniels DV, Jegere S, Kim HS, Dunning A, DeFrance T, Lansky A, Leipsic J, Min JK. Diagnosis of ischemia-causing coronary stenoses by noninvasive fractional flow reserve computed from coronary computed tomographic angiograms. Results from the prospective multicenter DISCOVER-FLOW (Diagnosis of Ischemia-Causing Stenoses Obtained Via Noninvasive Fractional Flow Reserve) study. J Am Coll Cardiol. 2011 Nov 1;58(19):1989-97. doi: 10.1016/j.jacc.2011.06.066.

Reference Type DERIVED
PMID: 22032711 (View on PubMed)

Other Identifiers

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H-1007-193-325

Identifier Type: -

Identifier Source: org_study_id

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