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临床试验/NCT00739869
NCT00739869已完成不适用

Effects of Hormone Therapy on Subclinical Neurological Pathology-The WHIMS-MRI Collaborative Study

National Heart, Lung, and Blood Institute (NHLBI)1 个研究点 分布在 1 个国家目标入组 1,426 人开始时间: 2004年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,426
试验地点
1
主要终点
Prevalence of silent infarcts in women assigned to HRT versus women assigned to placebo

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
65 Years 至 90 Years(Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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:
  • 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

结局指标

主要结局

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

时间窗: Measured at a single study visit

次要结局

未报告次要终点

研究者

申办方类型
Nih
责任方
Sponsor

研究点 (1)

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