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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

August 20, 2008

Last Updated Date

August 29, 2008

Start Date ^†

May 2004

Current 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 ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00739869 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

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

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.

Study Phase

Study Type ^†

Observational

Study Design ^†

Case Control, Cross-Sectional

Condition ^†

Hormone Replacement Therapy
Stroke

Intervention ^†

Study Arms / Comparison Groups

Participants will include women who participated in the WHIMS study.

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

1426

Completion Date

March 2007

Primary Completion Date

April 2006 (final data collection date for primary outcome measure)

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

Gender

Female

Ages

65 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00739869

Responsible Party

Sally A. Shumaker, PhD, Senior Associate Dean, Research, Wake Forest University Health Sciences

Secondary IDs ^††

N01-WH-4-4221

Study Sponsor ^†

National Heart, Lung, and Blood Institute (NHLBI)

Collaborators ^††

Investigators ^†

Principal Investigator:

Sally A. Shumaker, PhD

Wake Forest University

Information Provided By

National Heart, Lung, and Blood Institute (NHLBI)

Verification Date

August 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.