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Patterns of Coronary Artery Anatomy in Children With Congenital Heart Disease by Computed Tomography

Primary Purpose

Heart Diseases

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
CT
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Heart Diseases focused on measuring coronary artery

Eligibility Criteria

1 Day - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: - TOF, DORV, TGA, CCT Exclusion Criteria: -

Sites / Locations

  • National Taiwan University Hospital

Outcomes

Primary Outcome Measures

diagnostic accuracy

Secondary Outcome Measures

sensitivity
specificity

Full Information

First Posted
September 12, 2005
Last Updated
December 5, 2012
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00167011
Brief Title
Patterns of Coronary Artery Anatomy in Children With Congenital Heart Disease by Computed Tomography
Official Title
Patterns of Coronary Artery Anatomy in Children With Congenital Heart Disease by Computed Tomography
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
July 1995 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2002 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Taiwan University Hospital

4. Oversight

5. Study Description

Brief Summary
To test the ability of electron beam CT in evalting the coronary artery pattern in children with congenital heart disease.
Detailed Description
To test the ability of electron beam CT in evalting the coronary artery pattern in children with congenital heart disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Diseases
Keywords
coronary artery

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
CT
Primary Outcome Measure Information:
Title
diagnostic accuracy
Secondary Outcome Measure Information:
Title
sensitivity
Title
specificity

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - TOF, DORV, TGA, CCT Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shyh-Jye Chen, MD, PhD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

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Patterns of Coronary Artery Anatomy in Children With Congenital Heart Disease by Computed Tomography

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