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Screening and Access to Health Care for Vascular Disease

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ClinicalTrials.gov Identifier: NCT01889485
Recruitment Status : Unknown
Verified June 2019 by Omar Morcos, NorthShore University HealthSystem.
Recruitment status was:  Active, not recruiting
First Posted : June 28, 2013
Last Update Posted : June 26, 2019
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Omar Morcos, NorthShore University HealthSystem

Tracking Information
First Submitted Date June 26, 2013
First Posted Date June 28, 2013
Last Update Posted Date June 26, 2019
Study Start Date April 2013
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 27, 2013)
Geographic and racial differences in access to follow-up care if significant disease is identified through the screening event [ Time Frame: 5 years ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 27, 2013)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Screening and Access to Health Care for Vascular Disease
Official Title Screening and Access to Health Care for Vascular Disease in Urban and Suburban Patient Populations
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Ecologic or Community
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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).
Condition
  • Aortic Aneurysm, Abdominal
  • Carotid Stenosis
  • Peripheral Arterial Disease
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: June 27, 2013)
255
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 2020
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01889485
Other Study ID Numbers EH12-224
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Omar Morcos, NorthShore University HealthSystem
Study Sponsor Omar Morcos
Collaborators Medtronic
Investigators
Principal Investigator: Omar Morcos, MD NorthShore University HealthSystem
PRS Account NorthShore University HealthSystem
Verification Date June 2019