Back to resultsEvaluation of Thyroid Exposure to Radiation Doses During Paediatric Cardiac Catheterisations Performed for Diagnosis or the Treatment of Congenital Heart Disease
Primary Purpose
Cardiac Catheterizations
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood and urine samples ; Echography
Sponsored by
About this trial
This is an interventional prevention trial for Cardiac Catheterizations
Eligibility Criteria
Inclusion Criteria:
- Inclusion of any patient (< 18 year-old) with congenital heart disease undergoing one or more cardiac catheterization
Exclusion Criteria:
- Exclusion of patients with any type of thyroid dissease
Sites / Locations
- Assistance Publique Hopitaux de Marseille
Outcomes
Primary Outcome Measures
exposure to radiation measure
To determine the average risk for thyroid irradiation for any type of paediatric cardiac catheterization, based on the cummulative at-risk dose of 100 mSv, adjusted to the measured thyroid volume and to the patient's age.
Secondary Outcome Measures
exposure to radiation measure
Fit the dose of average irradiation of the thyroid during the catheterizations to the thyroïdien volume
Full Information
NCT ID
NCT01693796
First Posted
April 5, 2011
Last Updated
July 27, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT01693796
Brief Title
Evaluation of Thyroid Exposure to Radiation Doses During Paediatric Cardiac Catheterisations Performed for Diagnosis or the Treatment of Congenital Heart Disease
Official Title
Evaluation of Thyroid Exposure to Radiation Doses During Paediatric Cardiac Catheterisations Performed for Diagnosis or the Treatment of Congenital Heart Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine the average risk for thyroid irradiation for any type of paediatric cardiac catheterization, based on the cummulative at-risk dose of 100 mSv, adjusted to the measured thyroid volume and to the patient's age.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Catheterizations
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
blood and urine samples ; Echography
Primary Outcome Measure Information:
Title
exposure to radiation measure
Description
To determine the average risk for thyroid irradiation for any type of paediatric cardiac catheterization, based on the cummulative at-risk dose of 100 mSv, adjusted to the measured thyroid volume and to the patient's age.
Time Frame
2 YEARS
Secondary Outcome Measure Information:
Title
exposure to radiation measure
Description
Fit the dose of average irradiation of the thyroid during the catheterizations to the thyroïdien volume
Time Frame
2 YEARS
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Inclusion of any patient (< 18 year-old) with congenital heart disease undergoing one or more cardiac catheterization
Exclusion Criteria:
Exclusion of patients with any type of thyroid dissease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
BERNARD BELAIGUES
Organizational Affiliation
Assistance Publique hôpitaux de Marseille
Official's Role
Study Chair
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Thyroid Exposure to Radiation Doses During Paediatric Cardiac Catheterisations Performed for Diagnosis or the Treatment of Congenital Heart Disease
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