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Transluminal Attenuation Gradient Versus CT Fractional Flow Reserve

This study is currently recruiting participants.
Verified August 2011 by Seoul National University Hospital
Sponsor:
Collaborator:
Samsung Medical Center
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01413334
First received: August 9, 2011
Last updated: NA
Last verified: August 2011
History: No changes posted
  Purpose

Coronary computed tomographic angiography (CCTA) has emerged as a non-invasive test, accurately evaluate anatomic coronary artery stenosis. However, anatomically-obstructive coronary stenosis by CCTA demonstrates an unreliable relationship to lesion-specific ischemia. Recently, with the advance of imaging reconstruction and analysis technique, several novel parameters computed from CCTA were suggested to have added value in determining the ischemia-causing coronary stenosis. In this study, diagnostic performance of transluminal attenuation gradient (TAG) and fractional flow reserve computed form CCTA (FFR-CCTA) for the presence of hemodynamically-significant coronary stenosis, as determined by fractional flow reserve (FFR).


Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Noninvasive Diagnosis of Ischemia Causing Coronary Stenosis Using Coronary CT Angiograms (CCTA) : Comparison of Transluminal Attenuation Gradient (TAG) and Fractional Flow Reserve Computed From CCTA (FFR CT)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • fractional flow reserve [ Time Frame: 1day ] [ Designated as safety issue: No ]
    fractional flow reserve of stenotic coronary artery


Estimated Enrollment: 80
Study Start Date: May 2011
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Detailed Description:

Angiographically obtained fractional flow reserve (FFR) is a useful physiologic test for assessment of lesion-specific ischemia, and a valuable adjunct to anatomic assessment of coronary artery disease (CAD) as determined by invasive coronary angiography. However, the invasiveness and measuring difficulty of FFR make it unfamiliar to perform. Coronary computed tomographic angiography (CCTA) has emerged as a non-invasive test, accurately evaluate anatomic coronary artery stenosis. Although CCTA evaluation of CAD has been validated against invasive coronary angiography and intravascular ultrasound, anatomically-obstructive coronary stenosis by CCTA demonstrates an unreliable relationship to lesion-specific ischemia. Recently, with the advance of imaging reconstruction and analysis technique, several novel parameters computed from CCTA were suggested to have added value in determining the ischemia-causing coronary stenosis. In this study, diagnostic performance of transluminal attenuation gradient (TAG) and fractional flow reserve computed form CCTA (FFR-CCTA) for the presence of hemodynamically-significant coronary stenosis, as determined by FFR, will be compared to suggest best functional parameter noninvasively computed form CCTA.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with suspected or known coronary artery disease (CAD) who underwent coronary CT angiography, invasive coronary angiography, and fractional flow reserve measurement between May, 2010 and January, 2011

Criteria

Inclusion Criteria:

  • Age >= 18 years old
  • CCTA with >=50% stenosis in a major coronary artery (>=2.0 mm diameter)
  • underwent invasive coronary angiography with FFR measurement

Exclusion Criteria:

  • with CCTA of poor image quality
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01413334

Contacts
Contact: Bon-Kwon Koo, MD, PhD 82-2072-2062 bkkoo@snu.ac.kr
Contact: Yeonyee E Yoon, MD 82-2072-2677 islandtea@gmail.com

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Bon-Kwon Koo, MD, PhD     82-2-2072-2062     bkkoo@snu.ac.kr    
Contact: Yeonyee E Yoon, MD     82-2-2072-2677     islandtea@gmail.com    
Principal Investigator: Bon-Kwon Koo, MD, PhD            
Sub-Investigator: Yeonyee E Yoon, MD            
Sponsors and Collaborators
Seoul National University Hospital
Samsung Medical Center
Investigators
Principal Investigator: Bon-Kwon Koo, MD, PhD Seoul National University
  More Information

No publications provided

Responsible Party: Division of cardiology/Cardiovascular center, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01413334     History of Changes
Other Study ID Numbers: H-1106-076-366
Study First Received: August 9, 2011
Last Updated: August 9, 2011
Health Authority: South Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
Coronary artery disease
CT

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on June 13, 2013