Clinical trial NCT00739869: Evaluating the Effects of Hormone Replacement Therapy on Brain Function (The WHIMS-MRI Study)
Official title: Effects of Hormone Therapy on Subclinical Neurological Pathology-The WHIMS-MRI Collaborative Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
Collaborators: name: Wake Forest University Health Sciences
First posted: 2008-08-22
Enrollment: 1426
Sex: FEMALE
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who participated in the WHIMS study and receive medical care at clinics participating in this study.

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.

Eligibility criteria: 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 exclusion criteria may be eligible for participation, based on study staff approval:

  1. Metal fragments around critical soft tissue (i.e., shrapnel near spinal cord)
  2. Prosthetics
  3. Eyelid spring or wire
  4. Metallic stent, filter, or coil
  5. Breast tissue expander
  6. Tattoo or non-removable body piercing
  7. Difficulty lying flat
  8. Difficulty breathing
  9. Claustrophobia

Primary outcomes:
measure: Prevalence of silent infarcts in women assigned to HRT versus women assigned to placebo
timeFrame: Measured at a single study visit
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Sally A. Shumaker, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jaramillo SA, Felton D, Andrews L, Desiderio L, Hallarn RK, Jackson SD, Coker LH, Robinson JG, Ockene JK, Espeland MA; Women's Health Initiative Memory Study Research Group. Enrollment in a brain magnetic resonance study: results from the Women's Health Initiative Memory Study Magnetic Resonance Imaging Study (WHIMS-MRI). Acad Radiol. 2007 May;14(5):603-12. doi: 10.1016/j.acra.2007.02.001.