NCT00681681

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 21, 2008

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

November 8, 2017

Status Verified

December 1, 2014

Enrollment Period

4.9 years

First QC Date

May 19, 2008

Last Update Submit

November 6, 2017

Conditions

Stroke

Keywords

strokevascular markerstroke riskrisk factorssex differences

Outcome Measures

Primary Outcomes (1)

  • Carotid intimal medial thickness (IMT) and 10-year cardiovascular risk assessment. The primary analysis will focus on gender differences.

    3 years

Secondary Outcomes (1)

  • Brachial artery flow mediated dilation (BAFMD) and ankle-brachial index (ABI)

    3 years

Study Arms (1)

1

Men and women with 1 or more cardiovascular risk factors

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • One or more cardiovascular risk factors
  • non-insulin dependent diabetes
  • hypertension
  • hyperlipidemia
  • metabolic syndrome, (NCEP ATPIII criteria)
  • tobacco smoking

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157-1043, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

RNA and DNA samples collected

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Cheryl Bushnell, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2008

First Posted

May 21, 2008

Study Start

February 1, 2008

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

November 8, 2017

Record last verified: 2014-12

Locations

US(1)