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Evaluating the Effects of Hormone Replacement Therapy on Brain Function (The WHIMS-MRI Study)

Effects of Hormone Therapy on Subclinical Neurological Pathology-The WHIMS-MRI Collaborative Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00739869
Acronym
WHIMS-MRI
Enrollment
1426
Registered
2008-08-22
Start date
2004-05-31
Completion date
2007-03-31
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Silent Infarcts, Magnetic Resonance Imaging, MRI, Subclinical Cerebrovascular Disease, White Matter Grade Abnormalities, Total Brain Volume, Ventricular and Hippocampal Volume, Subclinical Vascular Abnormalities, Cerebrovascular Disease, CVD, Subclinical CVD

Brief summary

A silent stroke is a type of stroke that does not produce any severe symptoms, but may slightly affect memory or thinking abilities. Women who take hormone replacement therapy (HRT) may have a higher risk of experiencing a silent stroke than women who do not use HRT. This study will use magnetic resonance imaging (MRI) to determine the prevalence of silent strokes and other changes in brain tissue in women who participated in the Women's Health Initiative Memory Study (WHIMS), a study in which women received HRT, either as estrogen alone or as estrogen and progesterone combined, or placebo.

Detailed description

A silent stroke is a type of stroke that occurs as a result of blockage in the small blood vessels in the brain. Older adults, in particular, are at risk for silent strokes. This type of stroke does not cause any of the typical stroke symptoms, such as vision problems, facial numbness, or walking difficulties; however, subtle changes in a person's cognitive ability or memory may occur following a silent stroke. It is important to diagnose this type of stroke because several occurrences of silent strokes can increase the risk of having a more serious, and possibly fatal, stroke. As women go through menopause, many choose to take HRT to relieve common menopausal symptoms, including hot flashes and mood swings. Unfortunately, the use of HRT may place women at higher risk of experiencing a silent stroke. This study will assess whether women who take HRT, either as estrogen alone or as estrogen and progesterone combined, have a greater risk of silent stroke than women who do not take HRT. Study researchers will also examine changes in brain tissue and changes in the areas of the brain associated with thinking and memory. This study will enroll women who are participating in the WHIMS study. Participants will attend one study visit at which time a brain MRI scan will be completed. Study researchers will analyze participants' study data from the WHIMS study and the Women's Health Initiative Study of Cognitive Aging (WHISCA) study, an ancillary WHIMS study that examined the effects of HRT on memory and cognition.

Interventions

None listed

Sponsors

Wake Forest University Health Sciences
CollaboratorOTHER
National Heart, Lung, and Blood Institute (NHLBI)
Lead SponsorNIH

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
65 Years to 90 Years
Healthy volunteers
Yes

Inclusion criteria

* Participated in the WHIMS study * Receives medical care at 1 of the 13 WHIMS MRI clinics

Exclusion criteria

* Currently has a pacemaker (either working or non-functioning), intracranial aneurysm clip, neurostimulator, defibrillator, intra-ocular ferrous foreign body (e.g., metal in the eye), or Harrington rods * Currently has a magnetically or electrically activated device, including any of the following items: cochlear implant, transcutaneous electrical nerve stimulation (TENS) unit, implanted pump (insulin or infusion), or a McGee Stapes implant * Potential participants who have the following

Design outcomes

Primary

MeasureTime frame
Prevalence of silent infarcts in women assigned to HRT versus women assigned to placeboMeasured at a single study visit

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026