Screening and Access to Health Care for Vascular Disease

Sponsor
Omar Morcos (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01889485
Collaborator
Medtronic (Industry)
255
1
87
2.9

Study Details

Study Description

Brief Summary

This is a pilot study designed to validate our methods of recruitment, screening and data collection in the community. The project will help to establish the feasibility of the study design to lay the groundwork for a potentially larger study. The final study will allow us to estimate the incidence and prevalence of abdominal aortic aneurysm (AAA), carotid artery stenosis, and peripheral artery disease (PAD) in different geographic areas in a large urban setting, as well as determine patient access to healthcare and treatment for vascular disease as related to geographic and racial differences.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    255 participants
    Observational Model:
    Ecologic or Community
    Time Perspective:
    Prospective
    Official Title:
    Screening and Access to Health Care for Vascular Disease in Urban and Suburban Patient Populations
    Actual Study Start Date :
    Jun 1, 2014
    Anticipated Primary Completion Date :
    Sep 1, 2021
    Anticipated Study Completion Date :
    Sep 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Geographic and racial differences in access to follow-up care if significant disease is identified through the screening event [5 years]

    Secondary Outcome Measures

    1. Geographical and racial differences in patterns of accessing healthcare prior to the screening events. [1 year]

    2. Differences in rates of interventions throughout the 5 year follow-up period. [5 years]

    3. Differences in the rates of complications related to treatment of vascular disease in the various geographic areas in which the events are held. [5 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    55 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • age 55 or older

    • willing/able to provide consent

    • willing to participate in follow-up phone calls at defined intervals for up to 5 years

    Exclusion Criteria:
    • unable to provide consent to participate

    • unwilling/unable to participate in the follow-up phone call

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 NorthShore University HealthSystem Evanston Illinois United States 60201

    Sponsors and Collaborators

    • Omar Morcos
    • Medtronic

    Investigators

    • Principal Investigator: Omar Morcos, MD, NorthShore University HealthSystem

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Omar Morcos, Chief, Division of Vascular Surgery, NorthShore University HealthSystem
    ClinicalTrials.gov Identifier:
    NCT01889485
    Other Study ID Numbers:
    • EH12-224
    First Posted:
    Jun 28, 2013
    Last Update Posted:
    Sep 30, 2021
    Last Verified:
    Sep 1, 2021

    Study Results

    No Results Posted as of Sep 30, 2021