Sex Differences in Vascular Markers of Stroke Risk



Status:Completed
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:45 - 65
Updated:11/10/2017
Start Date:February 2008
End Date:January 2013

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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.

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.

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)
We found this trial at
1
site
1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
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