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Follow-up Study of the RAI-Treated Hyperthyroid Patients

NCT ID: NCT00471458

Last Updated: 2007-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5222 participants

Study Classification

OBSERVATIONAL

Study Start Date

1969-01-31

Study Completion Date

2003-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hyperthyroidism Cardiovascular Diseases Atrial Fibrillation

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tampere University

OTHER

Sponsor Role lead

Principal Investigators

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Saara Metso, MD

Role: PRINCIPAL_INVESTIGATOR

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

Pia Jaatinen, MD, PhD

Role: STUDY_DIRECTOR

Medical School, University of Tampere, Tampere, FINLAND

Jorma Salmi, MD, PhD

Role: STUDY_DIRECTOR

Tampere University Hopsital, Department of Internal Medicine, FIN-33521 TAMPERE, FINLAND

Locations

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Tampere University Hospital, Department of Internal Medicine

Tampere, , Finland

Site Status

Countries

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Finland

References

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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. doi: 10.1111/j.1365-2265.2004.02152.x.

Reference Type BACKGROUND
PMID: 15521969 (View on PubMed)

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. doi: 10.1002/cncr.22635.

Reference Type BACKGROUND
PMID: 17393376 (View on PubMed)

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. doi: 10.1210/jc.2006-2321. Epub 2007 Mar 20.

Reference Type BACKGROUND
PMID: 17374710 (View on PubMed)

Other Identifiers

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R02134

Identifier Type: -

Identifier Source: org_study_id