Cardiac Catheterizations Clinical Trial
Official title:
Evaluation of Thyroid Exposure to Radiation Doses During Paediatric Cardiac Catheterisations Performed for Diagnosis or the Treatment of Congenital Heart Disease
| Verified date | August 2015 |
| Source | Assistance Publique Hopitaux De Marseille |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 52 |
| Est. completion date | April 2015 |
| Est. primary completion date | April 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A to 18 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Assistance Publique Hopitaux de Marseille | Marseille |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique Hopitaux De Marseille |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | 2 YEARS | |
| Secondary | exposure to radiation measure | Fit the dose of average irradiation of the thyroid during the catheterizations to the thyroïdien volume | 2 YEARS |