Coronary Vessel Anomalies Clinical Trial
Official title:
Physiologic Evaluation of Anomalous Right Coronary Artery Stenosis
| Verified date | December 2013 |
| Source | Seoul National University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Korea: Food and Drug Administration |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 36 |
| Est. completion date | December 2013 |
| Est. primary completion date | December 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years to 85 Years |
| Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Seoul National University Hospital | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Seoul National University Hospital |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | cardiac death | 12 months | No |