Sex Differences in Vascular Markers of Stroke Risk (SAVVY)
|ClinicalTrials.gov Identifier: NCT00681681|
Recruitment Status : Completed
First Posted : May 21, 2008
Last Update Posted : November 8, 2017
|Condition or disease|
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 Type :||Observational|
|Actual Enrollment :||117 participants|
|Official Title:||Sex Differences in Vascular Markers of Stroke Risk|
|Study Start Date :||February 2008|
|Primary Completion Date :||January 2013|
|Study Completion Date :||January 2013|
Men and women with 1 or more cardiovascular risk factors
- Carotid intimal medial thickness (IMT) and 10-year cardiovascular risk assessment. The primary analysis will focus on gender differences. [ Time Frame: 3 years ]
- Brachial artery flow mediated dilation (BAFMD) and ankle-brachial index (ABI) [ Time Frame: 3 years ]
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00681681
|United States, North Carolina|
|Wake Forest University Health Sciences|
|Winston-Salem, North Carolina, United States, 27157-1043|
|Principal Investigator:||Cheryl Bushnell, MD||Associate Professor, Department of Neurology, Wake Forest University Health Sciences|