Overview

This trial is active, not recruiting.

Conditions aortic aneurysm, abdominal, carotid stenosis, peripheral arterial disease
Sponsor NavYash Gupta, MD
Collaborator Medtronic
Start date April 2013
End date August 2020
Trial size 255 participants
Trial identifier NCT01889485, EH12-224

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model ecologic or community
Time perspective prospective

Primary Outcomes

Measure
Geographic and racial differences in access to follow-up care if significant disease is identified through the screening event
time frame: 5 years

Secondary Outcomes

Measure
Geographical and racial differences in patterns of accessing healthcare prior to the screening events.
time frame: 1 year
Differences in rates of interventions throughout the 5 year follow-up period.
time frame: 5 years
Differences in the rates of complications related to treatment of vascular disease in the various geographic areas in which the events are held.
time frame: 5 years

Eligibility Criteria

Male or female participants at least 55 years old.

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

Additional Information

Official title Screening and Access to Health Care for Vascular Disease in Urban and Suburban Patient Populations
Principal investigator NavYash Gupta, MD
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by NorthShore University HealthSystem.