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Physiologic Evaluation of Anomalous Right Coronary Artery Stenosis

This study is currently recruiting participants.
Verified July 2011 by Seoul National University Hospital
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01133054
First received: May 26, 2010
Last updated: July 15, 2011
Last verified: July 2011
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

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

Estimated Enrollment: 30
Study Start Date: August 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01133054

Contacts
Contact: Kyungil Park, M.D. 82-2-2072-3757 ext 3757 cardiopark@gmail.com
Contact: Bon-Kwon KOO, M.D. 82-2-2072-2062 ext 2062 bkkoo@snu.ac.kr

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Kyungil Park, M.D.     82-2-2072-3757 ext 3757     cardiopark@gmail.com    
Contact: KOO Bon-Kwon, M.D.     82-2-2072-2062 ext 2062     bkkoo@snu.ac.kr    
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 / 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: July 15, 2011
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 May 22, 2013