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CompletedNCT01133054Updated Dec 3, 2013

Physiologic Evaluation of Anomalous Right Coronary Artery Stenosis

A Phase 4 interventional study of revascularization in Coronary Vessel Anomalies, sponsored by Seoul National University Hospital. Completed at 1 site in South Korea. Open to participants aged 20 Years to 85 Years. Per ClinicalTrials.gov, last updated 2013-12-03.

Sponsored by Seoul National University Hospital · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
36
Allocation
Non-randomized
Ages
20 Years to 85 Years
Sex
All
01

Study summary

The anomalous origin of right coronary artery (RCA) is a rare coronary anomaly. Recently, the detection of this anomaly has been more frequent as the use of cardiac multidetector computed tomography has become more popular. It can cause myocardial ischemia, syncope and sudden cardiac death. Surgical repair is generally recommended for symptomatic patients. However, there is controversy concerning the proper evaluation and treatment strategy for patients without documented myocardial ischemia.

The stenotic lesion of anomalous origin of RCA will be assessed by fractional flow reserve (FFR).

02

Conditions studied

  • Coronary Vessel Anomalies

Keywords

  • Coronary Vessel Anomalies
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In context

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,898 studies on the registry; 274 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients diagnosed as anomalous origin of right coronary artery from left coronary cusp

Exclusion criteria

Exclusion Criteria:

  • poor compliance
  • need for percutaneous coronary intervention to significant coronary lesion
  • failure of FFR for anomalous origin of right coronary artery
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    low FFR

    FFR\<0.75

    Procedure: revascularization

  • No intervention
    high FFR

    FFR \> 0.75

Interventions

  • Procedurerevascularization

    surgery or stenting

    Also known as: other names are not available

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What researchers measure

Primary outcomes

  1. cardiac death

    Time frame: 12 months

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Study locations

1 site
  • Seoul National University Hospital
    Seoul, 110-744, South Korea
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01133054
Responsible party
Bon-Kwon Koo (Associate professor, Seoul National University Hospital) — Principal investigator
First posted
May 28, 2010
Start date
Aug 2009
Primary completion
Dec 2013
Completion
Dec 2013
Last update
Dec 3, 2013

Study contacts

Bon-Kwon KOO, M.D.
study chair · Seoul National University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.

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