Transluminal Attenuation Gradient Versus CT Fractional Flow Reserve

NCT ID: NCT01413334

Last Updated: 2011-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Study Completion Date

2011-12-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Seoul National University Hospital

Principal Investigators

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Bon-Kwon Koo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Bon-Kwon Koo, MD, PhD

Role: CONTACT

82-2072-2062

Yeonyee E Yoon, MD

Role: CONTACT

82-2072-2677

Facility Contacts

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Bon-Kwon Koo, MD, PhD

Role: primary

82-2-2072-2062

Yeonyee E Yoon, MD

Role: backup

82-2-2072-2677

Other Identifiers

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H-1106-076-366

Identifier Type: -

Identifier Source: org_study_id

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