MedDataX Logo

Sex Differences in Vascular Markers of Stroke Risk

NCT ID: NCT00681681

Last Updated: 2017-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

117 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-02-29

Study Completion Date

2013-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

stroke vascular marker stroke risk risk factors sex differences

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Men and women with 1 or more cardiovascular risk factors

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Cheryl Bushnell, MD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor, Department of Neurology, Wake Forest University Health Sciences

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB00004014

Identifier Type: OTHER

Identifier Source: secondary_id

K02NS058760-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

K02NS058760

Identifier Type: NIH

Identifier Source: org_study_id

View Link