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Physiologic Evaluation of Anomalous Right Coronary Artery Stenosis

Sponsor
Seoul National University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01133054
Collaborator
(none)
36
Enrollment
1
Location
2
Arms
52
Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
  • Procedure: revascularization
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Physiologic Evaluation of Anomalous Right Coronary Artery Stenosis
Study Start Date :
Aug 1, 2009
Actual Primary Completion Date :
Dec 1, 2013
Actual Study Completion Date :
Dec 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: low FFR

FFR<0.75

Procedure: revascularization
surgery or stenting
Other Names:
  • other names are not available

    		•
    No Intervention: high FFR

    FFR > 0.75

    Outcome Measures

    Primary Outcome Measures

    1. cardiac death [12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • patients diagnosed as anomalous origin of right coronary artery from left coronary cusp
    Exclusion Criteria:

    • poor compliance

    • need for percutaneous coronary intervention to significant coronary lesion

    • failure of FFR for anomalous origin of right coronary artery

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National University Hospital Seoul Korea, Republic of 110-744

    Sponsors and Collaborators

    • Seoul National University Hospital

    Investigators

    • Study Chair: Bon-Kwon KOO, M.D., Seoul National University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bon-Kwon Koo, Associate professor, Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT01133054
    Other Study ID Numbers:
    • D-0908-010-060
    First Posted:
    May 28, 2010
    Last Update Posted:
    Dec 3, 2013
    Last Verified:
    Dec 1, 2013
    Keywords provided by Bon-Kwon Koo, Associate professor, Seoul National University Hospital
    Coronary Vessel Anomalies
    Additional relevant MeSH terms:
    Coronary Stenosis
    Coronary Vessel Anomalies

    Study Results

    No Results Posted as of Dec 3, 2013