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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

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: CT coronary angiography and computational fluid dynamics Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Non-invasive Functional Assessment of Coronary Stenoses Using CT Coronary Angiography and Computational Fluid Dynamics
Study Start Date : August 2010
Estimated Primary Completion Date : May 2014
Estimated Study Completion Date : July 2014

Arm Intervention/treatment
No Intervention: CT and FFR Device: CT coronary angiography and computational fluid dynamics
Evaluate coronary blood flow dynamics by CT coronary angiography and computational fluid dynamics




Primary Outcome Measures :
  1. fractional flow reserve [ Time Frame: 1day ]
    fractional flow reserve of stenotic coronary artery



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01189331


Contacts
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Contact: Bon-Kwon KOO, MD,PhD 82-2-2072-2062 bkkoo@snu.ac.kr

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110744
Principal Investigator: Bon-Kwon Koo, MD, PhD         
Sub-Investigator: Kyung-Woo Park, MD, PhD         
Sponsors and Collaborators
Seoul National University Hospital
Inje University
Pauls Stradins Clinical University Hospital
Cornell University
Ulsan university
Indiana University
Investigators
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Principal Investigator: Bon-Kwon Koo, MD, PhD Seoul National University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bon-Kwon Koo, Associate professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01189331    
Other Study ID Numbers: H-1007-193-325
First Posted: August 26, 2010    Key Record Dates
Last Update Posted: December 3, 2013
Last Verified: December 2013
Keywords provided by Bon-Kwon Koo, Seoul National University Hospital:
Coronary artery disease
CT
Computational flow dynamics
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases