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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00739869 |
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.
Condition |
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Hormone Replacement Therapy Stroke |
Study Type: | Observational |
Study Design: | Case Control, Cross-Sectional |
Official Title: | Effects of Hormone Therapy on Subclinical Neurological Pathology-The WHIMS-MRI Collaborative Study |
Enrollment: | 1426 |
Study Start Date: | May 2004 |
Study Completion Date: | March 2007 |
Primary Completion Date: | April 2006 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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1
Participants will include women who participated in the WHIMS study.
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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.
Ages Eligible for Study: | 65 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Women who participated in the WHIMS study and receive medical care at clinics participating in this study.
Inclusion Criteria:
Exclusion Criteria:
Potential participants who have the following exclusion criteria may be eligible for participation, based on study staff approval:
United States, North Carolina | |
Wake Forest University Health Sciences | |
Winston-Salem, North Carolina, United States, 27157 |
Principal Investigator: | Sally A. Shumaker, PhD | Wake Forest University |
Responsible Party: | Wake Forest University Health Sciences ( Sally A. Shumaker, PhD, Senior Associate Dean, Research ) |
Study ID Numbers: | 571, N01-WH-4-4221 |
Study First Received: | August 20, 2008 |
Last Updated: | August 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00739869 History of Changes |
Health Authority: | United States: Federal Government |
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 |
Cerebral Infarction Stroke Infarction |
Congenital Abnormalities Hormones Cerebrovascular Disorders |