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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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ClinicalTrials.gov Identifier: NCT01693796
Recruitment Status : Completed
First Posted : September 26, 2012
Last Update Posted : August 21, 2015
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

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.

Condition or disease Intervention/treatment Phase
Cardiac Catheterizations Other: blood and urine samples ; Echography Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of Thyroid Exposure to Radiation Doses During Paediatric Cardiac Catheterisations Performed for Diagnosis or the Treatment of Congenital Heart Disease
Study Start Date : March 2011
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. exposure to radiation measure [ Time Frame: 2 YEARS ]
    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 :
  1. exposure to radiation measure [ Time Frame: 2 YEARS ]
    Fit the dose of average irradiation of the thyroid during the catheterizations to the thyroïdien volume



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01693796


Locations
France
Assistance Publique Hopitaux de Marseille
Marseille, France, 13354
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Study Chair: BERNARD BELAIGUES Assistance Publique hôpitaux de Marseille

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT01693796     History of Changes
Other Study ID Numbers: 2010-A01118-31
2010-09 ( Other Identifier: AP HM )
First Posted: September 26, 2012    Key Record Dates
Last Update Posted: August 21, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities