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

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00739869
First received: August 20, 2008
Last updated: August 29, 2008
Last verified: August 2008
  Purpose

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
Hormone Replacement Therapy
Stroke

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • 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 ]

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
1
Participants will include women who participated in the WHIMS study.

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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Women who participated in the WHIMS study and receive medical care at clinics participating in this study.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00739869

Locations
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Investigators
Principal Investigator: Sally A. Shumaker, PhD Wake Forest School of Medicine
  More Information

Publications:
Responsible Party: Sally A. Shumaker, PhD, Senior Associate Dean, Research, Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00739869     History of Changes
Other Study ID Numbers: 571, N01-WH-4-4221
Study First Received: August 20, 2008
Last Updated: August 29, 2008
Health Authority: United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
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

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 28, 2014