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.
Verified September 2012 by Assistance Publique Hopitaux De Marseille
Sponsor:
Assistance Publique Hopitaux De Marseille
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
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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
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 May 19, 2013