StrokeWHIMS-MRINCT00739869
Evaluating the Effects of Hormone Replacement Therapy on Brain Function (The WHIMS-MRI Study)
An observational study of Stroke, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 90 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stroke
- How many people
- 1,426 participants
- Where
- 1 siteUnited States
- Study dates
- May 2004to Mar 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- Women only
- Healthy volunteers accepted
- Older adult
Study population: Women who participated in the WHIMS study and receive medical care at clinics participating in this study.
Who may be able to join
- Participated in the WHIMS study
- Receives medical care at 1 of the 13 WHIMS MRI clinics
Who cannot join
- 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
Show all 12Show fewer
- Metallic stent, filter, or coil
- Breast tissue expander
- Tattoo or non-removable body piercing
- Difficulty lying flat
- Difficulty breathing
- Claustrophobia
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Effects of Hormone Therapy on Subclinical Neurological Pathology-The WHIMS-MRI Collaborative Study
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.
Read the 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.
- 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
- Medical subject headings
- Stroke, Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Participants will include women who participated in the Women's Health Initiative Memory Study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of silent infarcts in women assigned to HRT versus women assigned to placebo
Measured: Measured at a single study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2008 (estimated)
- Study startMay 2004
- Primary completionApr 2006
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 1,426 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Wake Forest University Health Sciences
- Responsible party
- Sponsor
- Investigators
- Sally A. Shumaker, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00739869
- Sponsor's protocol ID
- 571
- Other IDs
- N01-WH-4-4221
- Acronym
- WHIMS-MRI
- Status last verified
- May 2024
- First submitted
- 20 Aug 2008
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.1016/j.acra.2007.02.001.
PubMed 17434074
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hormone Therapy on Subclinical Neurological Pathology-The WHIMS-MRI Collaborative Study
- ClinicalTrials.gov ID
- NCT00739869
- Acronym / sponsor ID
- WHIMS-MRI / 571
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,426 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Collaborators
- Wake Forest University Health Sciences
- Study start
- May 2004
- Primary completion
- Apr 2006 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 22 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Participants will include women who participated in the Women's Health Initiative Memory Study. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Women who participated in the WHIMS study and receive medical care at clinics participating in this study.
Key inclusion criteria (2 listed)
- Participated in the WHIMS study
- Receives medical care at 1 of the 13 WHIMS MRI clinics
Key exclusion criteria (12 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of silent infarcts in women assigned to HRT versus women assigned to placebo
Time frame: Measured at a single study visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
- Background: PubMed 17434074Jaramillo 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.
Related trials for Stroke
RecruitingPhase 1/2
Safety and Efficacy of CG-BM1 in Ischemic Stroke
Ischemic Stroke or High-risk TIA (ABCD² ≥ 4)
Not yet recruitingPhase 3
Recombinant Human Prourokinase for Acute Ischemic Stroke in the Extended Window Selected by CT-Based Artificial Intelligence
Acute Ischemic Stroke
Recruiting
Effects of Mirror Therapy and Motor Imagery on Upper Limb Motor Functions in Middle Cerebral Artery Stroke
Stroke
Recruiting
Rapid Local Ischemic Postconditioning on Stroke After Thrombectomy
Acute Ischemic Stroke
Not yet recruitingObservational study
The GEIR Registry: Rationale and Design of the First Nationwide Multicentre Retinal Stroke Registry in Spain
Retinal Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sally A. Shumaker, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of silent infarcts in women assigned to HRT versus women assigned to placebo (time frame: Measured at a single study visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00739869, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2024.