Follow-up Study of the RAI-Treated Hyperthyroid Patients

This study has been completed.
Sponsor:
Information provided by:
University of Tampere
ClinicalTrials.gov Identifier:
NCT00471458
First received: May 9, 2007
Last updated: NA
Last verified: May 2007
History: No changes posted
  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

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Official Title: Follow-up Study of Hyperthyroid Patients Treated With RAI in 1965-2002: Morbidity in Long-Term Follow-up

Resource links provided by NLM:


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

Keywords provided by University of Tampere:
Radioiodine
Hyperthyroidism
Morbidity
Cardiovascular diseases

Additional relevant MeSH terms:
Cardiovascular Diseases
Atrial Fibrillation
Hyperthyroidism
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes
Thyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 16, 2014