NCT00094237

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2004

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 15, 2004

Completed
Same day until next milestone

First Posted

Study publicly available on registry

October 15, 2004

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

April 25, 2017

Status Verified

December 1, 2015

Enrollment Period

2.8 years

First QC Date

October 15, 2004

Last Update Submit

April 21, 2017

Conditions

Cardiovascular DiseasesHeart DiseasesHypothyroidismMyocardial InfarctionCerebrovascular Accident

Eligibility Criteria

Age50 Years - 79 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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..

No eligibility criteria

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Cardiovascular DiseasesHeart DiseasesHypothyroidismMyocardial InfarctionStroke

Condition Hierarchy (Ancestors)

Thyroid DiseasesEndocrine System DiseasesMyocardial IschemiaVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Katherine Hartmann

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2004

First Posted

October 15, 2004

Study Start

September 1, 2004

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

April 25, 2017

Record last verified: 2015-12