Sex Differences in Vascular Markers of Stroke Risk

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00681681

Acronym

SAVVY

Enrollment

117

Registered

2008-05-21

Start date

2008-02-29

Completion date

2013-01-31

Last updated

2017-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

stroke, vascular marker, stroke risk, risk factors, sex differences

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

45 Years to 65 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
Carotid intimal medial thickness (IMT) and 10-year cardiovascular risk assessment. The primary analysis will focus on gender differences.	3 years

Secondary

Measure	Time frame
Brachial artery flow mediated dilation (BAFMD) and ankle-brachial index (ABI)	3 years

Countries

United States

Outcome results