Aortic Aneurysm, AbdominalNCT01889485
Screening and Access to Health Care for Vascular Disease
An observational study of Aortic Aneurysm, Abdominal and Carotid Stenosis, run by Endeavor Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aortic Aneurysm, Abdominal, Carotid Stenosis, Peripheral Arterial Disease
- How many people
- 190 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2014to May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- unable to provide consent to participate
- unwilling/unable to participate in the follow-up phone call
Trial locations and contacts
1 site in 1 country.
United States1 site
NorthShore University HealthSystem
Evanston, Illinois, 60201
About this study
Official title: 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.
- Keywords
- Aortic Aneurysm, Abdominal, Carotid Stenosis, Peripheral Arterial Disease, Health Services Accessibility
- Medical subject headings
- Aortic Aneurysm, Abdominal, Carotid Stenosis, Peripheral Arterial Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Geographic and racial differences in access to follow-up care if significant disease is identified through the screening event
Measured: 5 years
Secondary outcomes (3)
Geographical and racial differences in patterns of accessing healthcare prior to the screening events.
Measured: 1 year
Differences in rates of interventions throughout the 5 year follow-up period.
Measured: 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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2013 (estimated)
- Study start1 Jun 2014
- Primary completionMay 2021
- Study completionMay 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Aneurysm, AbdominalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endeavor Health
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Omar Morcos, MD, Principal investigator, Endeavor Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01889485
- Sponsor's protocol ID
- EH12-224
- Status last verified
- Jun 2023
- First submitted
- 26 Jun 2013
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening and Access to Health Care for Vascular Disease in Urban and Suburban Patient Populations
- ClinicalTrials.gov ID
- NCT01889485
- Acronym / sponsor ID
- EH12-224
- Keywords
- Aortic Aneurysm, Abdominal, Carotid Stenosis, Peripheral Arterial Disease, Health Services Accessibility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Endeavor HealthUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 1 Jun 2014 (actual)
- Primary completion
- May 2021 (actual)
- Study completion
- May 2021 (actual)
- First posted
- 28 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- unable to provide consent to participate
- unwilling/unable to participate in the follow-up phone call
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Geographic and racial differences in access to follow-up care if significant disease is identified through the screening event
Time frame: 5 years
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Omar Morcos, MD principal investigator
Endeavor Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Aneurysm, Abdominal and Carotid Stenosis, run by Endeavor Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geographic and racial differences in access to follow-up care if significant disease is identified through the screening event (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.