Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Physiologic Evaluation of Anomalous Right Coronary Artery Stenosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01133054
Recruitment Status : Completed
First Posted : May 28, 2010
Last Update Posted : December 3, 2013
Sponsor:
Information provided by (Responsible Party):
Bon-Kwon Koo, Seoul National University Hospital

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
Coronary Vessel Anomalies Procedure: revascularization Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : August 2009
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. cardiac death [ Time Frame: 12 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01133054


Locations
Layout table for location information
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Layout table for investigator information
Study Chair: Bon-Kwon KOO, M.D. Seoul National University Hospital

Layout table for additonal information
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    Key Record Dates
Last Update Posted: December 3, 2013
Last Verified: December 2013
Keywords provided by Bon-Kwon Koo, Seoul National University Hospital:
Coronary Vessel Anomalies
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronary Stenosis
Coronary Vessel Anomalies
Congenital Abnormalities
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities