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Physiologic Evaluation of Anomalous Right Coronary Artery Stenosis

NCT ID: NCT01133054

Last Updated: 2013-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2013-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Coronary Vessel Anomalies

Keywords

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Coronary Vessel Anomalies

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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low FFR

FFR\<0.75

Group Type EXPERIMENTAL

revascularization

Intervention Type PROCEDURE

surgery or stenting

high FFR

FFR \> 0.75

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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revascularization

surgery or stenting

Intervention Type PROCEDURE

Other Intervention Names

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other names are not available

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Bon-Kwon Koo

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bon-Kwon KOO, M.D.

Role: STUDY_CHAIR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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D-0908-010-060

Identifier Type: -

Identifier Source: org_study_id