Physiologic Evaluation of Anomalous Right Coronary Artery Stenosis

December 1, 2013 updated by: Bon-Kwon Koo, Seoul National University Hospital

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: low FFR
FFR<0.75
Procedure: revascularization
surgery or stenting
Other Names:
  • other names are not available
No Intervention: high FFR
FFR > 0.75

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
cardiac death
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Study Chair: Bon-Kwon KOO, M.D., Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

May 26, 2010

First Submitted That Met QC Criteria

May 26, 2010

First Posted (Estimate)

May 28, 2010

Study Record Updates

Last Update Posted (Estimate)

December 3, 2013

Last Update Submitted That Met QC Criteria

December 1, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D-0908-010-060

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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