Screening and Access to Health Care for Vascular Disease

NCT01889485 | Completed

• 1 other identifier: EH12-224
• Study Type: observational
• Target: 190
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Aneurysm, Abdominal; Carotid Stenosis; Peripheral Arterial Disease

Keywords

Aortic Aneurysm, Abdominal; Carotid Stenosis; Peripheral Arterial Disease; Health Services Accessibility

Outcome Measures

Primary Outcomes (1)

• Geographic and racial differences in access to follow-up care if significant disease is identified through the screening event

  5 years

Secondary Outcomes (3)

• Geographical and racial differences in patterns of accessing healthcare prior to the screening events.

  1 year

• Differences in rates of interventions throughout the 5 year follow-up period.

  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.

  5 years

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Volunteer subjects age 55 and over who sign informed consent will be enrolled in three separate neighborhoods in the Chicago area (North, South, West).

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Endeavor Health: lead
• Medtronic: collaborator

Study Sites (1)

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Carotid Stenosis; Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Atherosclerosis; Arteriosclerosis; Peripheral Vascular Diseases

Study Officials

• Omar Morcos, MD

  Endeavor Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2013
• First Posted: June 28, 2013
• Study Start: June 1, 2014
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: September 28, 2023

Record last verified: 2023-06

Locations

US (1)