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CompletedNCT01189331Updated Mar 16, 2021

CT Coronary Angiography and Computational Fluid Dynamics

An interventional study of CT coronary angiography and computational fluid dynamics in Coronary Artery Disease, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-16.

Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Oct 2009, registered Aug 2010).
Phase
Not applicable
Study type
Interventional
Enrollment
103
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Coronary Artery Disease

Keywords

  • Coronary artery disease
  • CT
  • Computational flow dynamics
03

In context

Coronary Artery Disease

5,596 studies on the registry are indexed under Coronary Artery Disease; 955 are open to participants now.

This study's enrollment of 103 is below the median of 123 across 3,435 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,859 studies on the registry; 274 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • total occlusion and collateral flow to target vessel
  • AV conduction abnormality
  • Left ventricular hypertrophy
  • significant valvular heart or primary myocardial disease
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
Single (Investigator)
Enrollment
103 participants (actual)

Study arms

  • No intervention
    CT and FFR

    Device: CT coronary angiography and computational fluid dynamics

Interventions

  • DeviceCT coronary angiography and computational fluid dynamics

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

06

What researchers measure

Primary outcomes

  1. fractional flow reserve

    fractional flow reserve of stenotic coronary artery

    Time frame: 1day

  2. target vessel failure

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

    Time frame: 10 year

07

Study locations

1 site
  • Seoul National University Hospital
    Seoul, 110744, Korea, Republic of
08

References and documents

Publications

  • 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. PubMed 22032711 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 16, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01189331
Lead sponsor
Seoul National University Hospital
Collaborators
Inje University, Pauls Stradins Clinical University Hospital, Cornell University, Ulsan university, Indiana University, Stanford University
Responsible party
Bon-Kwon Koo (Associate professor, Seoul National University Hospital) — Principal investigator
First posted
Aug 26, 2010
Start date
Oct 13, 2009
Primary completion
Dec 31, 2020
Completion
Dec 31, 2020
Last update
Mar 16, 2021

Study contacts

Bon-Kwon Koo, MD, PhD
principal investigator · Seoul National University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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