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

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ClinicalTrials.gov Identifier: NCT00167011
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : December 6, 2012
Sponsor:
Information provided by:
National Taiwan University Hospital

Tracking Information
First Submitted Date  ICMJE September 12, 2005
First Posted Date  ICMJE September 14, 2005
Last Update Posted Date December 6, 2012
Study Start Date  ICMJE July 1995
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
diagnostic accuracy
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00167011 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
  • sensitivity
  • specificity
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Patterns of Coronary Artery Anatomy in Children With Congenital Heart Disease by Computed Tomography
Official Title  ICMJE Patterns of Coronary Artery Anatomy in Children With Congenital Heart Disease by Computed Tomography
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Heart Diseases
Intervention  ICMJE Procedure: CT
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: September 12, 2005)
200
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2002
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

- TOF, DORV, TGA, CCT

Exclusion Criteria:

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00167011
Other Study ID Numbers  ICMJE 9461700813
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE National Taiwan University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Shyh-Jye Chen, MD, PhD National Taiwan University Hospital
PRS Account National Taiwan University Hospital
Verification Date November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP