Subclinical Thyroid Dysfunction and Risk of Myocardial Infarction and Stroke

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Katherine Hartmann, MD, PhD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00094237
First received: October 15, 2004
Last updated: December 16, 2015
Last verified: December 2015
  Purpose
To examine the association of subclinical hypothyroidism and risk of myocardial infarction and stroke in a large prospective cohort of post-menopausal women.

Condition
Cardiovascular Diseases
Heart Diseases
Hypothyroidism
Myocardial Infarction
Cerebrovascular Accident

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Subclinical Thyroid Dysfunction and Risk of Myocardial Infarction and Stroke

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Enrollment: 3200
Study Start Date: September 2004
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   50 Years to 79 Years   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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..
Criteria
No eligibility criteria
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00094237

Sponsors and Collaborators
Katherine Hartmann, MD, PhD
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Katherine Hartmann University of North Carolina, Chapel Hill
  More Information

Responsible Party: Katherine Hartmann, MD, PhD, Professor, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00094237     History of Changes
Other Study ID Numbers: 1274  R01HL076645 
Study First Received: October 15, 2004
Last Updated: December 16, 2015
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Infarction
Cardiovascular Diseases
Heart Diseases
Myocardial Infarction
Stroke
Hypothyroidism
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Vascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Thyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 26, 2016