Follow-up Study of the RAI-Treated Hyperthyroid Patients

Cardiovascular Diseases Clinical Trial

Official title:

Follow-up Study of Hyperthyroid Patients Treated With RAI in 1965-2002: Morbidity in Long-Term Follow-up

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00471458
• Other study ID #: R02134
• Status: Completed
• Phase: N/A
• First received: May 9, 2007
• Last updated: May 9, 2007
• Start date: January 1969
• Est. completion date: December 2003

Study information

• Verified date: May 2007
• Source: University of Tampere
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ministry of Social Affairs and Health
• Study type: Observational

Clinical Trial Summary

Previous studies of hyperthyroid patients suggest that they remain at increased risk of cardiovascular morbidity after restoring euthyroidism.

The study objective is to compare the rate and causes of hospitalization of hyperthyroid patients treated with radioactive iodine (RAI) with those of an age- and gender-matched reference population in a long-term follow-up study.

Description:

A population-based cohort study was conducted among 2611 hyperthyroid patients treated with RAI between 1969 and 2002 in Tampere University Hospital, and among 2611 reference subjects. A reference group was randomly selected, with an age- and gender-matched control subject identified for each patient from the Population Register Centre. The control subject had to be alive at the time when the patient received the first RAI treatment.

The causes of hospitalization as well as the diagnosis and date of hospital admission were obtained from the nationwide Hospital Discharge Register (HILMO) maintained by the Research and Development Centre for Welfare and Health (STAKES) using a computerized record linkage, with the personal identification number as the key. The HILMO database covers all dates and causes of hospitalization (hospital admission requiring an overnight stay) of the Finnish citizens since January 1969. New events were analyzed as the main outcome, including only the first hospitalization due to a given indication. The special focus was on the cardiovascular morbidity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5222
• Est. completion date: December 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients: Radioiodine treatment for hyperthyroidism given in the Tampere University Hospital between January 1969 and June 2002

• Controls: age- and gender-matched control subject identified for each patient from the Population Register Centre. The control subject had to be alive at the time when the patient received the first RAI treatment

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Atrial Fibrillation
• Cardiovascular Diseases
• Hyperthyroidism

Locations

Country	Name	City	State
Finland	Tampere University Hospital, Department of Internal Medicine	Tampere

Sponsors (1)

Lead Sponsor	Collaborator
University of Tampere

Country where clinical trial is conducted

Finland, 

References & Publications (3)

Metso S, Auvinen A, Huhtala H, Salmi J, Oksala H, Jaatinen P. Increased cancer incidence after radioiodine treatment for hyperthyroidism. Cancer. 2007 May 15;109(10):1972-9. Erratum in: Cancer. 2007 Oct 15;110(8):1875. — View Citation

Metso S, Jaatinen P, Huhtala H, Auvinen A, Oksala H, Salmi J. Increased cardiovascular and cancer mortality after radioiodine treatment for hyperthyroidism. J Clin Endocrinol Metab. 2007 Jun;92(6):2190-6. Epub 2007 Mar 20. Erratum in: J Clin Endocrinol Metab. 2007 Oct;92(10):4008. — View Citation

Metso S, Jaatinen P, Huhtala H, Luukkaala T, Oksala H, Salmi J. Long-term follow-up study of radioiodine treatment of hyperthyroidism. Clin Endocrinol (Oxf). 2004 Nov;61(5):641-8. — View Citation