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Screening and Access to Health Care for Vascular Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by NorthShore University HealthSystem
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
NavYash Gupta, MD, NorthShore University HealthSystem
ClinicalTrials.gov Identifier:
NCT01889485
First received: June 26, 2013
Last updated: September 23, 2014
Last verified: September 2014
  Purpose

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
Aortic Aneurysm, Abdominal
Carotid Stenosis
Peripheral Arterial Disease

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by NorthShore University HealthSystem:

Primary Outcome Measures:
  • Geographic and racial differences in access to follow-up care if significant disease is identified through the screening event [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Geographical and racial differences in patterns of accessing healthcare prior to the screening events. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Differences in rates of interventions throughout the 5 year follow-up period. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 255
Study Start Date: April 2013
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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).

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01889485

Contacts
Contact: Karen Hynes 847-663-8017 khynes@northshore.org
Contact: NavYash Gupta, MD 847-663-8050 ngupta2@northshore.org

Locations
United States, Illinois
NorthShore University HealthSystem Recruiting
Evanston, Illinois, United States, 60201
Contact: Karen Hynes    847-663-8017    khynes@northshore.org   
Principal Investigator: NavYash Gupta, MD         
Sub-Investigator: Tina Desai, MD         
Sub-Investigator: Omar Morcos, MD         
Sub-Investigator: Benjamin Lind, MD         
Sponsors and Collaborators
NavYash Gupta, MD
Medtronic
Investigators
Principal Investigator: NavYash Gupta, MD NorthShore University HealthSystem
  More Information

No publications provided

Responsible Party: NavYash Gupta, MD, Chief, Division of Vascular Surgery, NorthShore University HealthSystem
ClinicalTrials.gov Identifier: NCT01889485     History of Changes
Other Study ID Numbers: EH12-224
Study First Received: June 26, 2013
Last Updated: September 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by NorthShore University HealthSystem:
Aortic Aneurysm, Abdominal
Carotid Stenosis
Peripheral Arterial Disease
Health Services Accessibility

Additional relevant MeSH terms:
Carotid Stenosis
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Peripheral Arterial Disease
Peripheral Vascular Diseases
Vascular Diseases
Aortic Diseases
Arterial Occlusive Diseases
Arteriosclerosis
Atherosclerosis
Brain Diseases
Cardiovascular Diseases
Carotid Artery Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on November 19, 2014