CT Coronary Angiography and Computational Fluid Dynamics

NCT01189331 | Completed DMC

• 1 other identifier: H-1007-193-325
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease

Keywords

Coronary artery disease; CT; Computational flow dynamics

Outcome Measures

Primary Outcomes (2)

• fractional flow reserve

  fractional flow reserve of stenotic coronary artery

  1day

• target vessel failure

  composite of cardiovascular death, target vessel myocardial infarction, target vessel revascularization

  10 year

Study Arms (1)

CT and FFR

NO INTERVENTION

Device: CT coronary angiography and computational fluid dynamics

Interventions

CT coronary angiography and computational fluid dynamics DEVICE

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

CT and FFR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Inje University: collaborator
• Pauls Stradins Clinical University Hospital: collaborator
• Cornell University: collaborator
• Ulsan university: collaborator
• Indiana University: collaborator
• Stanford University: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, 110744, South Korea

Location

Related Publications (3)

• 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.

  PMID: 38378313 DERIVED

• 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.

  PMID: 36872186 DERIVED

• 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.

  PMID: 22032711 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Bon-Kwon Koo, MD, PhD

  Seoul National University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: With masking value of FFR derived from coronary CT angiography to the investigators, FFR is measured and patients have been followed-up.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: August 15, 2010
• First Posted: August 26, 2010
• Study Start: October 13, 2009
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: March 16, 2021

Record last verified: 2021-03

Locations

KR (1)