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Sex Differences in Vascular Markers of Stroke Risk (SAVVY)

This study has been completed.
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Cheryl Bushnell, Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT00681681
First received: May 19, 2008
Last updated: December 10, 2014
Last verified: December 2014
History of Changes
  Purpose

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
Stroke

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sex Differences in Vascular Markers of Stroke Risk

Further study details as provided by Wake Forest School of Medicine:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Brachial artery flow mediated dilation (BAFMD) and ankle-brachial index (ABI) [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

RNA and DNA samples collected
Enrollment: 117
Study Start Date: February 2008
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Men and women with 1 or more cardiovascular risk factors

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.

  Eligibility
Ages Eligible for Study:   45 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00681681

Locations
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157-1043
Sponsors and Collaborators
Wake Forest School of Medicine
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

No publications provided

Responsible Party: Cheryl Bushnell, Associate Professor of Neurology, Wake Forest School of Medicine
ClinicalTrials.gov Identifier: NCT00681681     History of Changes
Other Study ID Numbers: K02NS058760, IRB00004014, K02NS058760-01A1
Study First Received: May 19, 2008
Last Updated: December 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest School of Medicine:
stroke
vascular marker
stroke risk
risk factors
sex differences

ClinicalTrials.gov processed this record on March 03, 2015