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NCT01889485 Clinical Trial

Screening and Access to Health Care for Vascular Disease

Peripheral Arterial Disease Clinical Trial

Official title:
Screening and Access to Health Care for Vascular Disease in Urban and Suburban Patient Populations

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01889485
Other study ID # EH12-224
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2014
Est. completion date May 2021

Study information
Verified date June 2023
Source NorthShore University HealthSystem
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 190
Est. completion date May 2021
Est. primary completion date May 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 55 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States NorthShore University HealthSystem Evanston Illinois

Sponsors (2)
Lead Sponsor Collaborator
NorthShore University HealthSystem Medtronic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Geographic and racial differences in access to follow-up care if significant disease is identified through the screening event 5 years
Secondary Geographical and racial differences in patterns of accessing healthcare prior to the screening events. 1 year
Secondary Differences in rates of interventions throughout the 5 year follow-up period. 5 years
Secondary 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
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