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

NCT00739869 | Completed DMC

• 2 other identifiers: 571N01-WH-4-4221
• Study Type: observational
• Target: 1,426
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Prevalence of silent infarcts in women assigned to HRT versus women assigned to placebo

  Measured at a single study visit

Study Arms (1)

1

Participants will include women who participated in the Women's Health Initiative Memory Study.

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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
• Metal fragments around critical soft tissue (i.e., shrapnel near spinal cord)
• Prosthetics
• Eyelid spring or wire
• Metallic stent, filter, or coil
• Breast tissue expander
• Tattoo or non-removable body piercing
• Difficulty lying flat
• Difficulty breathing
• Claustrophobia

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead
• Wake Forest University Health Sciences: collaborator

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (1)

• 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.

  PMID: 17434074 BACKGROUND

MeSH Terms

Conditions

Stroke; Cerebrovascular Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Sally A. Shumaker, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2008
• First Posted: August 22, 2008
• Study Start: May 1, 2004
• Primary Completion: April 1, 2006
• Study Completion: March 1, 2007
• Last Updated: May 6, 2024

Record last verified: 2024-05

Locations

US (1)