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Follow-up Study of the RAI-Treated Hyperthyroid Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00471458
First Posted: May 10, 2007
Last Update Posted: May 10, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Tampere
  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
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Retrospective
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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: May 9, 2007
First Posted: May 10, 2007
Last Update Posted: May 10, 2007
Last Verified: May 2007

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

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


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