Physiologic Evaluation of Anomalous Right Coronary Artery Stenosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bon-Kwon Koo, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01133054
First received: May 26, 2010
Last updated: December 1, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Coronary Vessel Anomalies
Procedure: revascularization
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Physiologic Evaluation of Anomalous Right Coronary Artery Stenosis

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • cardiac death [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: August 2009
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: low FFR
FFR<0.75
Procedure: revascularization
surgery or stenting
Other Name: other names are not available
No Intervention: high FFR
FFR > 0.75

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01133054

Locations
Korea, Republic of
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
  More Information

No publications provided

Responsible Party: Bon-Kwon Koo, Associate professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01133054     History of Changes
Other Study ID Numbers: D-0908-010-060
Study First Received: May 26, 2010
Last Updated: December 1, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
Coronary Vessel Anomalies

Additional relevant MeSH terms:
Congenital Abnormalities
Coronary Vessel Anomalies
Coronary Stenosis
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Coronary Disease
Myocardial Ischemia
Vascular Diseases

ClinicalTrials.gov processed this record on July 23, 2014