Sex Differences in Vascular Markers of Stroke Risk (SAVVY)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Wake Forest School of Medicine.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT00681681
First received: May 19, 2008
Last updated: June 28, 2010
Last verified: September 2009

May 19, 2008
June 28, 2010
February 2008
January 2012   (final data collection date for 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00681681 on ClinicalTrials.gov Archive Site
Brachial artery flow mediated dilation (BAFMD) and ankle-brachial index (ABI) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Sex Differences in Vascular Markers of Stroke Risk
Sex Differences in Vascular Markers of Stroke Risk

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

Stroke
Not Provided
1
Men and women with 1 or more cardiovascular risk factors
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
250
January 2013
January 2012   (final data collection date for primary outcome measure)

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)
Both
45 Years to 65 Years
No
Contact: Nancy C. Buchheimer, BS 336-716-3961 nbuchhe@wfubmc.edu
United States
 
NCT00681681
K02NS058760, IRB00004014, K02NS058760-01A1
No
Cheryl Bushnell, MD, Associate Professor, Department of Neurology, Wake Forest University Health Sciences
Wake Forest School of Medicine
National Institute of Neurological Disorders and Stroke (NINDS)
Principal Investigator: Cheryl Bushnell, MD Associate Professor, Department of Neurology, Wake Forest University Health Sciences
Wake Forest School of Medicine
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP