Subclinical Thyroid Dysfunction and Risk of Myocardial Infarction and Stroke

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gerardo Heiss, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00094237
First received: October 15, 2004
Last updated: March 24, 2014
Last verified: March 2014

October 15, 2004
March 24, 2014
September 2004
July 2007   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00094237 on ClinicalTrials.gov Archive Site
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Subclinical Thyroid Dysfunction and Risk of Myocardial Infarction and Stroke
Subclinical Thyroid Dysfunction and Risk of Myocardial Infarction and Stroke

To examine the association of subclinical hypothyroidism and risk of myocardial infarction and stroke in a large prospective cohort of post-menopausal women.

BACKGROUND:

Cardiovascular disease, including myocardial infarction (MI) and stroke, is the leading cause of death for women in the United States. Subclinical hypothyroidism (SCH), in which thyroid hormone levels are in the normal range but thyroid stimulating hormone (TSH) is elevated, has been linked to abnormal lipid profiles, atherosclerosis, and MI. The literature is scant however, and the evidence constrained by small studies, many of cross-sectional design. Both the US Preventive Services Task Force and the Institute of Medicine recently concluded that current data are insufficient to inform clinical decision-making about the need for screening or treatment for SCH.

DESIGN NARRATIVE:

This is a case-cohort study within the 93,676-member Observational Study of the Women's Health Initiative, including 800 women who have experienced an MI, 750 with thrombotic/embolic stroke, and a randomly selected subcohort of 3,200 women density-matched for age, race/ethnicity, and clinical center. Participants have extensive baseline demographic, health, behavioral, and physical exam data and stored serum available. The investigators will measure TSH and thyroid hormone levels in order to identify SCH at entry. Follow-up includes annual health status updates and a physical exam in the third year; >=5 years have passed since enrollment for all women. Thus, using new laboratory studies and existing Women's Health Initiative (WHI) data, they will be able to answer these primary research questions: Among women without a history of thyroid disease, MI, or stroke: 1) Is subclinical hypothyroidism at baseline independently associated with risk of MI? 2) Is subclinical hypothyroidism at baseline independently associated with risk of ischemic stroke? 3) What form of association best describes the relationship between TSH, as a continuous measure, and risk of MI and stroke? 4) What are the population correlates (i.e., race/ethnicity, body mass index (BMI), hormone therapy, comorbidity) of SCH? This information - currently unavailable for middle-aged and older women - is germane to public health and health care policy to define the burden of illness associated with SCH, and to quantify the benefits and costs of eventual population screening and treatment

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

Postmenopausal women aged 50-79 years, who enrolled in the Women's Health Initiative (WHI) Observational Study (n=93,676). Participants include African American, Asian, Hispanic/Latino and European-American individuals recruited from the communities surrounding the WHI study centers..

  • Cardiovascular Diseases
  • Heart Diseases
  • Hypothyroidism
  • Myocardial Infarction
  • Cerebrovascular Accident
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3200
July 2007
July 2007   (final data collection date for primary outcome measure)

No eligibility criteria

Female
50 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT00094237
1274, R01HL076645
No
Gerardo Heiss, University of North Carolina, Chapel Hill
Gerardo Heiss
National Heart, Lung, and Blood Institute (NHLBI)
Investigator: Katherine Hartmann University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP