NCT01413334

Brief 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 9, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 10, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

August 10, 2011

Status Verified

August 1, 2011

Enrollment Period

3 months

First QC Date

August 9, 2011

Last Update Submit

August 9, 2011

Conditions

Keywords

Coronary artery diseaseCT

Outcome Measures

Primary Outcomes (1)

  • fractional flow reserve

    fractional flow reserve of stenotic coronary artery

    1day

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • with CCTA of poor image quality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Bon-Kwon Koo, MD, PhD

    Seoul National University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bon-Kwon Koo, MD, PhD

CONTACT

Yeonyee E Yoon, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 9, 2011

First Posted

August 10, 2011

Study Start

May 1, 2011

Primary Completion

August 1, 2011

Study Completion

December 1, 2011

Last Updated

August 10, 2011

Record last verified: 2011-08

Locations