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CT Coronary Angiography and Computational Fluid Dynamics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01189331
Recruitment Status : Unknown
Verified December 2013 by Bon-Kwon Koo, Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : August 26, 2010
Last Update Posted : December 3, 2013
Sponsor:
Collaborators:
Inje University
Pauls Stradins Clinical University Hospital
Cornell University
Ulsan university
Indiana University
Information provided by (Responsible Party):
Bon-Kwon Koo, Seoul National University Hospital

Tracking Information
First Submitted Date  ICMJE August 15, 2010
First Posted Date  ICMJE August 26, 2010
Last Update Posted Date December 3, 2013
Study Start Date  ICMJE August 2010
Estimated Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 25, 2010)
fractional flow reserve [ Time Frame: 1day ]
fractional flow reserve of stenotic coronary artery
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CT Coronary Angiography and Computational Fluid Dynamics
Official Title  ICMJE Non-invasive Functional Assessment of Coronary Stenoses Using CT Coronary Angiography and Computational Fluid Dynamics
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE Device: CT coronary angiography and computational fluid dynamics
Evaluate coronary blood flow dynamics by CT coronary angiography and computational fluid dynamics
Study Arms  ICMJE No Intervention: CT and FFR
Intervention: Device: CT coronary angiography and computational fluid dynamics
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 1, 2013)
300
Original Estimated Enrollment  ICMJE
 (submitted: August 25, 2010)
30
Estimated Study Completion Date  ICMJE July 2014
Estimated Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01189331
Other Study ID Numbers  ICMJE H-1007-193-325
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bon-Kwon Koo, Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE
  • Inje University
  • Pauls Stradins Clinical University Hospital
  • Cornell University
  • Ulsan university
  • Indiana University
Investigators  ICMJE
Principal Investigator: Bon-Kwon Koo, MD, PhD Seoul National University
PRS Account Seoul National University Hospital
Verification Date December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP