Aortic Aneurysm, AbdominalNCT02463760
Predicting Rupture of AAA by Anatomic and Hemodynamic Markers
An observational study of Aortic Aneurysm, Abdominal, run by University of Minnesota at 1 site in United States.
Trial summary
The purpose of the study is to investigate imaging findings, which can help us to predict factors contributing to abdominal aortic aneurysm growth and rupture. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Aortic Aneurysm, Abdominal
- What is being tested?
- Medical imaging
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to 14 Feb 2022
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primary and specialty care clinics and emergency room visits.
Who may be able to join
- Individuals between 18 and 80 years old receiving medical care at University of Minnesota Medical Center who have a normal aorta CTA within the previous year
- Or patients with known AAA with growth rate of 0-0.2 cm/year
- Or patients with known AAA with growth rate of greater than 0.5 cm/year.
Who cannot join
- Subjects with ferromagnetic implants
- Penile implant
- Hip replacement
- History of shrapnel or shot gun injury
- Body mass index ≥ 30
- Cardiac pacemakers
- Severe claustrophobia
- Large tattoos on the torso
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Predicting Rupture of Abdominal Aortic Aneurysm (AAA) by Anatomic and Hemodynamic Markers From In-vivo and In-vitro Imaging
The purpose of the study is to investigate imaging findings, which can help us to predict factors contributing to abdominal aortic aneurysm growth and rupture.
- Conditions
- Aortic Aneurysm, Abdominal
- Being tested
- Medical imaging
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical imagingOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Imaging findings correlating with abdominal aortic aneurysm growth and rupture
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2015 (estimated)
- Study startAug 2015
- Primary completion14 Feb 2022
- Study completion14 Feb 2022
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.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Rosenberg, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02463760
- Sponsor's protocol ID
- 150023
- Status last verified
- Mar 2022
- First submitted
- 2 Jun 2015
- Last updated
- 18 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Rupture of Abdominal Aortic Aneurysm (AAA) by Anatomic and Hemodynamic Markers From In-vivo and In-vitro Imaging
- ClinicalTrials.gov ID
- NCT02463760
- Acronym / sponsor ID
- 150023
- Conditions
- Aortic Aneurysm, Abdominal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- 14 Feb 2022 (actual)
- Study completion
- 14 Feb 2022 (actual)
- First posted
- 4 Jun 2015 (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.
The purpose of the study is to investigate imaging findings, which can help us to predict factors contributing to abdominal aortic aneurysm growth and rupture.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary and specialty care clinics and emergency room visits.
Key inclusion criteria (3 listed)
- Individuals between 18 and 80 years old receiving medical care at University of Minnesota Medical Center who have a normal aorta CTA within the previous year
- Or patients with known AAA with growth rate of 0-0.2 cm/year
- Or patients with known AAA with growth rate of greater than 0.5 cm/year.
Key exclusion criteria (8 listed)
- Subjects with ferromagnetic implants
- Penile implant
- Hip replacement
- History of shrapnel or shot gun injury
- Body mass index ≥ 30
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical imaging | Other | – |
Primary outcome
Imaging findings correlating with abdominal aortic aneurysm growth and rupture
Time frame: 1 year
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 18 Mar 2022.
- Individual participant dataSharing planned: Undecided
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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.
Michael Rosenberg, MD principal investigator
University of Minnesota
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, run by University of Minnesota 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 8 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 18 Mar 2022. 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?
Imaging findings correlating with abdominal aortic aneurysm growth and rupture (time frame: 1 year). 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 18 Mar 2022.