Back to resultsCT Coronary Angiography and Computational Fluid Dynamics
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CT coronary angiography and computational fluid dynamics
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring Coronary artery disease, CT, Computational flow dynamics
Eligibility Criteria
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
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm Type
No Intervention
Arm Label
CT and FFR
Arm Description
Outcomes
Primary Outcome Measures
fractional flow reserve
fractional flow reserve of stenotic coronary artery
target vessel failure
composite of cardiovascular death, target vessel myocardial infarction, target vessel revascularization
Secondary Outcome Measures
Full Information
NCT ID
NCT01189331
First Posted
August 15, 2010
Last Updated
March 12, 2021
Sponsor
Seoul National University Hospital
Collaborators
Inje University, Pauls Stradins Clinical University Hospital, Cornell University, Ulsan university, Indiana University, Stanford University
1. Study Identification
Unique Protocol Identification Number
NCT01189331
Brief Title
CT Coronary Angiography and Computational Fluid Dynamics
Official Title
Non-invasive Functional Assessment of Coronary Stenoses Using CT Coronary Angiography and Computational Fluid Dynamics
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
October 13, 2009 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Inje University, Pauls Stradins Clinical University Hospital, Cornell University, Ulsan university, Indiana University, Stanford University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary artery disease, CT, Computational flow dynamics
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Masking Description
With masking value of FFR derived from coronary CT angiography to the investigators, FFR is measured and patients have been followed-up.
Allocation
N/A
Enrollment
103 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CT and FFR
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
CT coronary angiography and computational fluid dynamics
Intervention Description
Evaluate coronary blood flow dynamics by CT coronary angiography and computational fluid dynamics
Primary Outcome Measure Information:
Title
fractional flow reserve
Description
fractional flow reserve of stenotic coronary artery
Time Frame
1day
Title
target vessel failure
Description
composite of cardiovascular death, target vessel myocardial infarction, target vessel revascularization
Time Frame
10 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bon-Kwon Koo, MD, PhD
Organizational Affiliation
Seoul National University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110744
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
22032711
Citation
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.
Results Reference
derived
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CT Coronary Angiography and Computational Fluid Dynamics
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