Back to resultsPhysiologic Evaluation of Anomalous Right Coronary Artery Stenosis
Primary Purpose
Coronary Vessel Anomalies
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
revascularization
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Vessel Anomalies focused on measuring Coronary Vessel Anomalies
Eligibility 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
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
low FFR
high FFR
Arm Description
FFR<0.75
FFR > 0.75
Outcomes
Primary Outcome Measures
cardiac death
Secondary Outcome Measures
Full Information
NCT ID
NCT01133054
First Posted
May 26, 2010
Last Updated
December 1, 2013
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01133054
Brief Title
Physiologic Evaluation of Anomalous Right Coronary Artery Stenosis
Official Title
Physiologic Evaluation of Anomalous Right Coronary Artery Stenosis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Data Monitoring Committee
No
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Vessel Anomalies
Keywords
Coronary Vessel Anomalies
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
low FFR
Arm Type
Experimental
Arm Description
FFR<0.75
Arm Title
high FFR
Arm Type
No Intervention
Arm Description
FFR > 0.75
Intervention Type
Procedure
Intervention Name(s)
revascularization
Other Intervention Name(s)
other names are not available
Intervention Description
surgery or stenting
Primary Outcome Measure Information:
Title
cardiac death
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bon-Kwon KOO, M.D.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Physiologic Evaluation of Anomalous Right Coronary Artery Stenosis
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