Evaluation of Thyroid Exposure to Radiation Doses During Paediatric Cardiac Catheterisations Performed for Diagnosis or the Treatment of Congenital Heart Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Assistance Publique Hopitaux De Marseille
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT01693796
First received: April 5, 2011
Last updated: September 24, 2012
Last verified: September 2012
  Purpose

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 Intervention
Cardiac Catheterizations
Other: blood and urine samples ; Echography

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • exposure to radiation measure [ Time Frame: 2 YEARS ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 YEARS ] [ Designated as safety issue: No ]
    Fit the dose of average irradiation of the thyroid during the catheterizations to the thyroïdien volume


Estimated Enrollment: 500
Study Start Date: March 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01693796

Contacts
Contact: alain fraisse alain.fraisse@ap-hm.fr

Locations
France
Assistance Publique Hopitaux de Marseille Recruiting
Marseille, France, 13354
Contact: alain FRAISSE       alain.fraisse@ap-hm.fr   
Principal Investigator: alain fraisse         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Study Chair: BERNARD BELAIGUES Assistance Publique hôpitaux de Marseille
  More Information

No publications provided

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT01693796     History of Changes
Other Study ID Numbers: 2010-A01118-31, 2010-09
Study First Received: April 5, 2011
Last Updated: September 24, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on August 28, 2014