NCT01133054

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2009

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 28, 2010

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

December 3, 2013

Status Verified

December 1, 2013

Enrollment Period

4.3 years

First QC Date

May 26, 2010

Last Update Submit

December 1, 2013

Conditions

Coronary Vessel Anomalies

Keywords

Coronary Vessel Anomalies

Outcome Measures

Primary Outcomes (1)

  • cardiac death

    12 months

Study Arms (2)

low FFR

EXPERIMENTAL

FFR\<0.75

Procedure: revascularization

high FFR

NO INTERVENTION

FFR \> 0.75

Interventions

revascularizationPROCEDURE

surgery or stenting

Also known as: other names are not available
low FFR

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients diagnosed as anomalous origin of right coronary artery from left coronary cusp

You may not qualify if:

  • poor compliance
  • need for percutaneous coronary intervention to significant coronary lesion
  • failure of FFR for anomalous origin of right coronary artery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Coronary Vessel Anomalies

Condition Hierarchy (Ancestors)

Heart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Bon-Kwon KOO, M.D.

    Seoul National University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

May 26, 2010

First Posted

May 28, 2010

Study Start

August 1, 2009

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

December 3, 2013

Record last verified: 2013-12

Locations

KR(1)