Clinical Trial: Iodinated Contrast Agents and Risk of Hypothyroidism in Young Children in the United States
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: Iodinated Contrast Agents and Risk of Hypothyroidism in Young Children in the United States
Brief Summary: This study will estimate the incidence of hypothyroidism in a pediatric population of children under age 4, based on data from the US-based Kaiser Permanente Northern California database, which were exposed to iodinated contrast agent through having a diagnostic procedure.
Detailed Summary:
Sponsor: Bayer
Current Primary Outcome: Number of pediatric patients with detected hypothyroidism after iodinated contrast exposure in a routine clinical practice setting [ Time Frame: Up to one year after exposure ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Reason to have a procedure with iodinated contrast agents [ Time Frame: At baseline ]Selected out of the following two options: Ventriculography,Cardio/Coronary angiography.
- Age [ Time Frame: At baseline ]Baseline characteristics of hypothyroidism cases
- Comorbidities [ Time Frame: At baseline ]Baseline characteristics of hypothyroidism cases
- Time in between iodine contrast exposure and diagnosis of hypothyroidism [ Time Frame: Up to one year after exposure ]
Original Secondary Outcome: Same as current
Information By: Bayer
Dates:
Date Received: October 11, 2016
Date Started: October 15, 2016
Date Completion: May 15, 2017
Last Updated: April 20, 2017
Last Verified: April 2017
