Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00094237
Status:
COMPLETED
Last Update Posted:
2017-04-25
First Post:
2004-10-15
Brief Title:
Subclinical Thyroid Dysfunction and Risk of Myocardial Infarction and Stroke
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Subclinical Thyroid Dysfunction and Risk of Myocardial Infarction and Stroke
Status:
COMPLETED
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To examine the association of subclinical hypothyroidism and risk of myocardial infarction and stroke in a large prospective cohort of post-menopausal women
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 93676-member Observational Study of the Womens Health Initiative including 800 women who have experienced an MI 750 with thromboticembolic stroke and a randomly selected subcohort of 3200 women density-matched for age raceethnicity 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 Womens 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 ie raceethnicity 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
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 93676-member Observational Study of the Womens Health Initiative including 800 women who have experienced an MI 750 with thromboticembolic stroke and a randomly selected subcohort of 3200 women density-matched for age raceethnicity 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 Womens 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 ie raceethnicity 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL076645 | NIH | None | httpsreporternihgovquickSearchR01HL076645 |