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CT Coronary Angiography and Computational Fluid Dynamics

Sponsor
Seoul National University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01189331
Collaborator
Inje University (Other), Pauls Stradins Clinical University Hospital (Other), Cornell University (Other), Ulsan university (Other), Indiana University (Other), Stanford University (Other)
103
Enrollment
1
Location
1
Arm
134.6
Actual Duration (Months)
0.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: CT coronary angiography and computational fluid dynamics
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
103 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
Single (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.
Primary Purpose:
Diagnostic
Official Title:
Non-invasive Functional Assessment of Coronary Stenoses Using CT Coronary Angiography and Computational Fluid Dynamics
Actual Study Start Date :
Oct 13, 2009
Actual Primary Completion Date :
Dec 31, 2020
Actual Study Completion Date :
Dec 31, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. fractional flow reserve [1day]

    fractional flow reserve of stenotic coronary artery

  2. target vessel failure [10 year]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Seoul National University Hospital Seoul Korea, Republic of 110744

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Bon-Kwon Koo, MD, PhD, Seoul National University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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:
Aug 26, 2010
Last Update Posted:
Mar 16, 2021
Last Verified:
Mar 1, 2021
Keywords provided by Bon-Kwon Koo, Associate professor, Seoul National University Hospital
Coronary artery disease
CT
Computational flow dynamics
Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease

Study Results

No Results Posted as of Mar 16, 2021