Evaluating the Effects of Hormone Replacement Therapy on Brain Function (The WHIMS-MRI Study)
|Study Design:||Observational Model: Case Control
Time Perspective: Cross-Sectional
|Official Title:||Effects of Hormone Therapy on Subclinical Neurological Pathology-The WHIMS-MRI Collaborative Study|
- Prevalence of silent infarcts in women assigned to HRT versus women assigned to placebo [ Time Frame: Measured at a single study visit ] [ Designated as safety issue: No ]
|Study Start Date:||May 2004|
|Study Completion Date:||March 2007|
|Primary Completion Date:||April 2006 (Final data collection date for primary outcome measure)|
Participants will include women who participated in the Women's Health Initiative Memory Study.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00739869
|United States, North Carolina|
|Wake Forest University Health Sciences|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||Sally A. Shumaker, PhD||Wake Forest School of Medicine|