Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2026-01-05 @ 1:18 AM
Study NCT ID:
NCT00471458
Status:
COMPLETED
Last Update Posted:
2007-05-10
First Post:
2007-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Follow-up Study of the RAI-Treated Hyperthyroid Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006980', 'term': 'Hyperthyroidism'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'DEFINED_POPULATION'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5222}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1969-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-05', 'completionDateStruct': {'date': '2003-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-05-09', 'studyFirstSubmitDate': '2007-05-09', 'studyFirstSubmitQcDate': '2007-05-09', 'lastUpdatePostDateStruct': {'date': '2007-05-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-05-10', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Radioiodine', 'Hyperthyroidism', 'Morbidity', 'Cardiovascular diseases'], 'conditions': ['Hyperthyroidism', 'Cardiovascular Diseases', 'Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '15521969', 'type': 'BACKGROUND', '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. doi: 10.1111/j.1365-2265.2004.02152.x.'}, {'pmid': '17393376', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '17374710', 'type': 'BACKGROUND', '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. doi: 10.1210/jc.2006-2321. Epub 2007 Mar 20.'}]}, 'descriptionModule': {'briefSummary': 'Previous studies of hyperthyroid patients suggest that they remain at increased risk of cardiovascular morbidity after restoring euthyroidism.\n\nThe 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.', 'detailedDescription': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients: Radioiodine treatment for hyperthyroidism given in the Tampere University Hospital between January 1969 and June 2002\n* 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'}, 'identificationModule': {'nctId': 'NCT00471458', 'briefTitle': 'Follow-up Study of the RAI-Treated Hyperthyroid Patients', 'organization': {'class': 'OTHER', 'fullName': 'Tampere University'}, 'officialTitle': 'Follow-up Study of Hyperthyroid Patients Treated With RAI in 1965-2002: Morbidity in Long-Term Follow-up', 'orgStudyIdInfo': {'id': 'R02134'}}, 'contactsLocationsModule': {'locations': [{'zip': '33521', 'city': 'Tampere', 'country': 'Finland', 'facility': 'Tampere University Hospital, Department of Internal Medicine', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}], 'overallOfficials': [{'name': 'Saara Metso, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tampere University Hospital, Department of Internal Medicine, FIN-33521 Tampere, Finland'}, {'name': 'Pia Jaatinen, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medical School, University of Tampere, Tampere, FINLAND'}, {'name': 'Jorma Salmi, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tampere University Hopsital, Department of Internal Medicine, FIN-33521 TAMPERE, FINLAND'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tampere University', 'class': 'OTHER'}}}}