- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01889485
Screening and Access to Health Care for Vascular Disease
September 25, 2023 updated by: NorthShore University HealthSystem
Screening and Access to Health Care for Vascular Disease in Urban and Suburban Patient Populations
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.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
190
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Illinois
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Evanston, Illinois, United States, 60201
- NorthShore University Healthsystem
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years and older (Adult, Older Adult)
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).
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Geographic and racial differences in access to follow-up care if significant disease is identified through the screening event
Time Frame: 5 years
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Geographical and racial differences in patterns of accessing healthcare prior to the screening events.
Time Frame: 1 year
|
1 year
|
Differences in rates of interventions throughout the 5 year follow-up period.
Time Frame: 5 years
|
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
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Omar Morcos, MD, NorthShore University Healthsystem
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2014
Primary Completion (Actual)
May 1, 2021
Study Completion (Actual)
May 1, 2021
Study Registration Dates
First Submitted
June 26, 2013
First Submitted That Met QC Criteria
June 27, 2013
First Posted (Estimated)
June 28, 2013
Study Record Updates
Last Update Posted (Actual)
September 28, 2023
Last Update Submitted That Met QC Criteria
September 25, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Atherosclerosis
- Carotid Artery Diseases
- Aortic Diseases
- Vascular Diseases
- Peripheral Arterial Disease
- Peripheral Vascular Diseases
- Carotid Stenosis
- Aneurysm
- Aortic Aneurysm
- Aortic Aneurysm, Abdominal
Other Study ID Numbers
- EH12-224
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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