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Sex Differences in Vascular Markers of Stroke Risk (SAVVY)

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ClinicalTrials.gov Identifier: NCT00681681
Recruitment Status : Completed
First Posted : May 21, 2008
Last Update Posted : November 8, 2017
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease
Stroke

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
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Study Type : Observational
Actual Enrollment : 117 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sex Differences in Vascular Markers of Stroke Risk
Study Start Date : February 2008
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013
Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
1
Men and women with 1 or more cardiovascular risk factors


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Carotid intimal medial thickness (IMT) and 10-year cardiovascular risk assessment. The primary analysis will focus on gender differences. [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Brachial artery flow mediated dilation (BAFMD) and ankle-brachial index (ABI) [ Time Frame: 3 years ]

Biospecimen Retention:   Samples With DNA
RNA and DNA samples collected

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   45 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

One or more cardiovascular risk factors

  • non-insulin dependent diabetes
  • hypertension
  • hyperlipidemia
  • metabolic syndrome, (NCEP ATPIII criteria)
  • tobacco smoking

Exclusion Criteria:

  • history of prior stroke (ischemic or hemorrhagic)
  • TIA
  • known carotid stenosis
  • peripheral vascular disease
  • coronary heart disease
  • venous thromboembolism
  • polycystic ovarian syndrome,
  • morbid obesity (BMI > 45 kg/m2)
  • women using hormone therapy (hormone replacement, contraceptive pills or patches)
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00681681


Locations
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157-1043
Sponsors and Collaborators
Wake Forest University Health Sciences
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: Cheryl Bushnell, MD Associate Professor, Department of Neurology, Wake Forest University Health Sciences
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00681681     History of Changes
Other Study ID Numbers: K02NS058760 ( U.S. NIH Grant/Contract )
IRB00004014 ( Other Identifier: Wake Forest University Health Sciences )
K02NS058760-01A1 ( U.S. NIH Grant/Contract )
First Posted: May 21, 2008    Key Record Dates
Last Update Posted: November 8, 2017
Last Verified: December 2014

Keywords provided by Wake Forest University Health Sciences:
stroke
vascular marker
stroke risk
risk factors
sex differences

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases