Transluminal Attenuation Gradient Versus CT Fractional Flow Reserve

Coronary Artery Disease Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01413334
• Other study ID #: H-1106-076-366
• Status: Recruiting
• Phase: N/A
• First received: August 9, 2011
• Last updated: August 9, 2011
• Start date: May 2011
• Est. completion date: December 2011

Study information

• Verified date: August 2011
• Source: Seoul National University Hospital
• Contact: Bon-Kwon Koo, MD, PhD
• Phone: 82-2072-2062
• Email: bkkoo[@]snu.ac.kr
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fractional flow reserve	fractional flow reserve of stenotic coronary artery	1day	No