Follow-up Study of the RAI-Treated Hyperthyroid Patients - Full Text View

Sponsored by:	University of Tampere
Information provided by:	University of Tampere
ClinicalTrials.gov Identifier:	NCT00471458

Purpose

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.

Condition
Hyperthyroidism Cardiovascular Diseases Atrial Fibrillation

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

U.S. FDA Resources

Study Type:	Observational
Study Design:	Natural History, Longitudinal, Defined Population, Retrospective Study
Official Title:	Follow-up Study of Hyperthyroid Patients Treated With RAI in 1965-2002: Morbidity in Long-Term Follow-up

Further study details as provided by University of Tampere:

Enrollment:	5222
Study Start Date:	January 1969
Study Completion Date:	December 2003

Detailed 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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00471458

Locations

Finland
Tampere University Hospital, Department of Internal Medicine
Tampere, Finland, 33521

Sponsors and Collaborators

University of Tampere

Investigators

Principal Investigator:	Saara Metso, MD	Tampere University Hospital, Department of Internal Medicine, FIN-33521 Tampere, Finland
Study Director:	Pia Jaatinen, MD, PhD	Medical School, University of Tampere, Tampere, FINLAND
Study Director:	Jorma Salmi, MD, PhD	Tampere University Hopsital, Department of Internal Medicine, FIN-33521 TAMPERE, FINLAND

More Information

Publications:

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.

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.

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 Mar 20; [Epub ahead of print]

Study ID Numbers:	R02134
Study First Received:	May 9, 2007
Last Updated:	May 9, 2007
ClinicalTrials.gov Identifier:	NCT00471458
Health Authority:	Finland: Ministry of Social Affairs and Health

Keywords provided by University of Tampere:

Radioiodine
Hyperthyroidism
Morbidity
Cardiovascular diseases

Study placed in the following topic categories:

Heart Diseases
Endocrine System Diseases
Endocrinopathy
Atrial Fibrillation

Thyroid Diseases
Hyperthyroidism
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009