StrokeSAVVYNCT00681681
Sex Differences in Vascular Markers of Stroke Risk
An observational study of Stroke, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The purposes of this study are to quantify and compare vascular function in men and women, and to determine the effect of age, race-ethnicity, cardiovascular risk factors, biological markers and hormonal markers on vascular measures to establish gender-specific models. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Stroke
- How many people
- 117 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Jan 2013
- 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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be recruited from primary care clinics, which may include internal medicine, family practice, and obstetrics/gynecology within the Wake Forest University health system.
Who may be able to join
- One or more cardiovascular risk factors
- non-insulin dependent diabetes
- hypertension
- hyperlipidemia
- metabolic syndrome, (NCEP ATPIII criteria)
- tobacco smoking
Who cannot join
- history of prior stroke (ischemic or hemorrhagic)
- TIA
- known carotid stenosis
- peripheral vascular disease
- coronary heart disease
- venous thromboembolism
Show all 9Show fewer
- polycystic ovarian syndrome,
- morbid obesity (BMI > 45 kg/m2)
- women using hormone therapy (hormone replacement, contraceptive pills or patches)
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157-1043
About this study
The purposes of this study are to quantify and compare vascular function in men and women, and to determine the effect of age, race-ethnicity, cardiovascular risk factors, biological markers and hormonal markers on vascular measures to establish gender-specific models.
Read the detailed description
Men and women with stroke have different risk factor profiles. Women tend to develop stroke risk factors, subclinical disease, and have vascular events following menopause, presumably related to the depletion of estrogen. Men, however, tend to develop vascular disease at a younger age. Sex differences in subclinical disease are poorly understood. Identification of subclinical disease could lead to more aggressive interventions to prevent stroke and other vascular events.
The objectives of this study are to quantify and compare vascular function in men and women by measuring carotid atherosclerosis, endothelial dysfunction, and ankle-brachial index and then to determine the effect of age, race-ethnicity, cardiovascular risk factors, biological markers and hormonal markers on these vascular measures to determine gender-specific models. The aims of this project are to determine if middle-aged men and women at risk for stroke have differences in functional and structural vascular assessments, and to develop comprehensive vascular health profiles in men and women.
In this trial, researchers will use a cross-sectional design to study gender differences in vascular functions and other vascular risk factors in 150 women and 100 men with 1 or more cardiovascular risk factors but without evidence of stroke, heart disease, or peripheral vascular disease. Participants will be divided in two age groups: 45 to 54 and 55 to 64 and will be followed for two years for vascular outcomes, such as stroke, transient ischemic attack or TIA, or acute coronary syndromes.
Information from this study will help develop a comprehensive gender-specific model of subclinical disease, discover novel biological and vascular markers for stroke, and provide critical data to be used in future studies aimed at slowing progression of vascular dysfunction and preventing stroke.
- Conditions
- Stroke
- Keywords
- stroke, vascular marker, stroke risk, risk factors, sex differences
- Medical subject headings
- Stroke
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 | Men and women with 1 or more cardiovascular risk factors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carotid intimal medial thickness (IMT) and 10-year cardiovascular risk assessment. The primary analysis will focus on gender differences.
Measured: 3 years
Secondary outcomes (1)
Brachial artery flow mediated dilation (BAFMD) and ankle-brachial index (ABI)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2008 (estimated)
- Study startFeb 2008
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cheryl Bushnell, MD, Principal investigator, Associate Professor, Department of Neurology, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00681681
- Sponsor's protocol ID
- K02NS058760
- Other IDs
- IRB00004014, K02NS058760-01A1
- Acronym
- SAVVY
- Status last verified
- Dec 2014
- First submitted
- 19 May 2008
- Last updated
- 8 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sex Differences in Vascular Markers of Stroke Risk
- ClinicalTrials.gov ID
- NCT00681681
- Acronym / sponsor ID
- SAVVY / K02NS058760
- Conditions
- Stroke
- Keywords
- stroke, vascular marker, stroke risk, risk factors, sex differences
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Feb 2008
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 21 May 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.
The purposes of this study are to quantify and compare vascular function in men and women, and to determine the effect of age, race-ethnicity, cardiovascular risk factors, biological markers and hormonal markers on vascular measures to establish gender-specific models.
Detailed description
Men and women with stroke have different risk factor profiles. Women tend to develop stroke risk factors, subclinical disease, and have vascular events following menopause, presumably related to the depletion of estrogen. Men, however, tend to develop vascular disease at a younger age. Sex differences in subclinical disease are poorly understood. Identification of subclinical disease could lead to more aggressive interventions to prevent stroke and other vascular events.
The objectives of this study are to quantify and compare vascular function in men and women by measuring carotid atherosclerosis, endothelial dysfunction, and ankle-brachial index and then to determine the effect of age, race-ethnicity, cardiovascular risk factors, biological markers and hormonal markers on these vascular measures to determine gender-specific models. The aims of this project are to determine if middle-aged men and women at risk for stroke have differences in functional and structural vascular assessments, and to develop comprehensive vascular health profiles in men and women.
In this trial, researchers will use a cross-sectional design to study gender differences in vascular functions and other vascular risk factors in 150 women and 100 men with 1 or more cardiovascular risk factors but without evidence of stroke, heart disease, or peripheral vascular disease. Participants will be divided in two age groups: 45 to 54 and 55 to 64 and will be followed for two years for vascular outcomes, such as stroke, transient ischemic attack or TIA, or acute coronary syndromes.
Information from this study will help develop a comprehensive gender-specific model of subclinical disease, discover novel biological and vascular markers for stroke, and provide critical data to be used in future studies aimed at slowing progression of vascular dysfunction and preventing stroke.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Men and women with 1 or more cardiovascular risk factors |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from primary care clinics, which may include internal medicine, family practice, and obstetrics/gynecology within the Wake Forest University health system.
Key inclusion criteria (6 listed)
- One or more cardiovascular risk factors
- non-insulin dependent diabetes
- hypertension
- hyperlipidemia
- metabolic syndrome, (NCEP ATPIII criteria)
Key exclusion criteria (9 listed)
- history of prior stroke (ischemic or hemorrhagic)
- TIA
- known carotid stenosis
- peripheral vascular disease
- coronary heart disease
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
Carotid intimal medial thickness (IMT) and 10-year cardiovascular risk assessment. The primary analysis will focus on gender differences.
Time frame: 3 years
1 secondary outcome
Brachial artery flow mediated dilation (BAFMD) and ankle-brachial index (ABI)
Time frame: 3 years
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 8 Nov 2017.
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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.
Cheryl Bushnell, MD principal investigator
Associate Professor, Department of Neurology, 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 Wake Forest University Health Sciences 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 6 inclusion and 9 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 8 Nov 2017. 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?
Carotid intimal medial thickness (IMT) and 10-year cardiovascular risk assessment. The primary analysis will focus on gender differences. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Nov 2017.