Abdominal Aortic AneurysmAAA-MRENCT02387255
Magnetic Resonance Elastography in Patients With Abdominal Aortic Aneurysms
An observational study of Abdominal Aortic Aneurysm, run by Ohio State University at 1 site in United States.
Trial summary
The main objective of this study is to utilize Magnetic Resonance Elastography (MRE) to determine tissue stiffness of abdominal aortic aneurysms (AAA). For patients with AAA, MRE is a more sensitive and superior method of determining the risk for rupture of AAA based on stiffness estimates when compared to the… Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Abdominal Aortic Aneurysm
- What is being tested?
- Resoundant Driver System
- Type of treatment
- Medical device
- How many people
- 165 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to 31 Oct 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. Normal volunteers are control group 2. Patients who are being monitored for diameter of AAA 3. Patients who will undergo surgical repair of AAA
Who may be able to join
- Must be able to lie flat on their back in the scanner for up to 60 minutes
- Must be able to hold breath for up to 15 seconds
Who cannot join
- Patients who are claustrophobic
- Patients who are pregnant
- Patients with any unapproved, non-MRI save metal/devices in or on their body
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Ohio State University Medical Center
Columbus, Ohio, 43210
Kristin L Thompson, B.S., 614-366-5429, Kristin.Thompson@osumc.edu
Arunark Kolipaka, PhD
About this study
The main objective of this study is to utilize Magnetic Resonance Elastography (MRE) to determine tissue stiffness of abdominal aortic aneurysms (AAA). For patients with AAA, MRE is a more sensitive and superior method of determining the risk for rupture of AAA based on stiffness estimates when compared to the current, crude method of assessing risk based on measurement of the diameter of the aneurysm. The investigators will also validate the stiffness estimates against gold standard i.e. mechanical testing and histopathology only AAA patients undergoing AAA surgery.
Read the detailed description
Currently, MRE is a clinical tool used to assess hepatic fibrosis at many institutions. MRE is superior to invasive techniques (i.e. biopsies) and mechanical testing in that it is noninvasive and can be performed in vivo under physiologic conditions. MRE could make diagnosing stiffness widely available and could revolutionize the diagnosis and treatment of numerous other diseases affecting stiffness of soft tissues.
Aortic wall "stiffness" is a fundamental biomechanical parameter that reflects the structural integrity of normal and aneurysmal aortic tissue. AAAs enlarge over time leading to sudden rupture and death in up to 90% of patients. Surgical or endovascular aneurysm repair (EVAR) is recommended for AAAs > 5.5 cm in diameter. However, previous studies have reported a high percentage (13%) of smaller AAAs (<5 cm) go on to rupture, and an even higher percentage (60%) of larger AAAs (>5 cm) remain stable. Despite the poor prognostic value of aortic diameter, it is still the primary parameter used to time surgical repair. It is known that changes in stiffness of AAA can reveal important information on extra-cellular matrix content; a key factor in the pathophysiological development of AAA and the risk for rupture. A non-invasive, spatially resolved estimate of aortic stiffness may provide a superior determinant of the risk for rupture compared to the currently used anatomical measures. The relationship between non-invasively measured wall stiffness (WS) and the structural integrity of the aortic wall must be further elucidated. Therefore, aortic MRE can be used as a noninvasive tool to estimate the stiffness of AAAs and can provide superior diagnostic and prognostic information in patients with developing AAA disease.
Entry to this study is open to men and women aged 18 years and older, and to all racial and ethnic subgroups. Two separate groups of patients with AAA will be recruited. One group will be patients who have been diagnosed with AAA and are monitored to observe the size of the AAA. The other group is comprised of patients who are scheduled for surgical repair of AAA.
- Conditions
- Abdominal Aortic Aneurysm
- Being tested
- Resoundant Driver System
- 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.
Resoundant Driver SystemDevice
Also called Driver
This device is used to generate vibrations at the area of interest. The device has an active driver, a loud speaker sitting outside the scanner area, and a passive driver, which is shaped like a silicone paddle, which is secured with velcro straps to the area being imaged. Sound waves from the active driver travel through a tube attached to the passive driver and generate vibrations, images of which are captured by the MR scanner.
| Study group | Role | What they receive |
|---|---|---|
| Normal Volunteers | 60 normal volunteers will be recruited. Each volunteer will undergo a single MRE scan (with Resoundant driver System ) of their abdominal aorta. Receives: Device: Resoundant Driver System | |
| Patients with AAA | Fifty to sixty five patients with AAA will be recruited. These patients will undergo MRE (with Resoundant driver system) of their AAA every six months for three years, or until the study ends or until the time of surgical repair or death due to rupture of AAA or other causes. Receives: Device: Resoundant Driver System | |
| Open Surgical Repair Patients | Fifty to sixty five patients patients undergoing open surgical repair will be recruited and undergo MRE (with Resoundant driver system) prior to surgery Receives: Device: Resoundant Driver System |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRE-Derived Shear Stiffness in kPa
Use of MRE stiffness estimates to determine rupture
Measured: Upto 36 months at every 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2015 (estimated)
- Study startOct 2014
- Primary completion31 Oct 2030 (estimated)
- Study completion31 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arunark Kolipaka, Ohio State University
- Investigators
- Arunark Kolipaka, PhD, Principal investigator, The Ohio State University Medical Center Dept. of Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02387255
- Sponsor's protocol ID
- 2013H0416
- Acronym
- AAA-MRE
- Status last verified
- Oct 2026
- First submitted
- 19 Feb 2015
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Elastography in Patients With Abdominal Aortic Aneurysms
- ClinicalTrials.gov ID
- NCT02387255
- Acronym / sponsor ID
- AAA-MRE / 2013H0416
- Conditions
- Abdominal Aortic Aneurysm
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- 31 Oct 2030 (estimated)
- Study completion
- 31 Oct 2030 (estimated)
- First posted
- 12 Mar 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 main objective of this study is to utilize Magnetic Resonance Elastography (MRE) to determine tissue stiffness of abdominal aortic aneurysms (AAA). For patients with AAA, MRE is a more sensitive and superior method of determining the risk for rupture of AAA based on stiffness estimates when compared to the current, crude method of assessing risk based on measurement of the diameter of the aneurysm. The investigators will also validate the stiffness estimates against gold standard i.e. mechanical testing and histopathology only AAA patients undergoing AAA surgery.
Detailed description
Currently, MRE is a clinical tool used to assess hepatic fibrosis at many institutions. MRE is superior to invasive techniques (i.e. biopsies) and mechanical testing in that it is noninvasive and can be performed in vivo under physiologic conditions. MRE could make diagnosing stiffness widely available and could revolutionize the diagnosis and treatment of numerous other diseases affecting stiffness of soft tissues.
Aortic wall "stiffness" is a fundamental biomechanical parameter that reflects the structural integrity of normal and aneurysmal aortic tissue. AAAs enlarge over time leading to sudden rupture and death in up to 90% of patients. Surgical or endovascular aneurysm repair (EVAR) is recommended for AAAs > 5.5 cm in diameter. However, previous studies have reported a high percentage (13%) of smaller AAAs (<5 cm) go on to rupture, and an even higher percentage (60%) of larger AAAs (>5 cm) remain stable. Despite the poor prognostic value of aortic diameter, it is still the primary parameter used to time surgical repair. It is known that changes in stiffness of AAA can reveal important information on extra-cellular matrix content; a key factor in the pathophysiological development of AAA and the risk for rupture. A non-invasive, spatially resolved estimate of aortic stiffness may provide a superior determinant of the risk for rupture compared to the currently used anatomical measures. The relationship between non-invasively measured wall stiffness (WS) and the structural integrity of the aortic wall must be further elucidated. Therefore, aortic MRE can be used as a noninvasive tool to estimate the stiffness of AAAs and can provide superior diagnostic and prognostic information in patients with developing AAA disease.
Entry to this study is open to men and women aged 18 years and older, and to all racial and ethnic subgroups. Two separate groups of patients with AAA will be recruited. One group will be patients who have been diagnosed with AAA and are monitored to observe the size of the AAA. The other group is comprised of patients who are scheduled for surgical repair of AAA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal Volunteers | – | Device: Resoundant Driver System60 normal volunteers will be recruited. Each volunteer will undergo a single MRE scan (with Resoundant driver System ) of their abdominal aorta. |
| Patients with AAA | – | Device: Resoundant Driver SystemFifty to sixty five patients with AAA will be recruited. These patients will undergo MRE (with Resoundant driver system) of their AAA every six months for three years, or until the study ends or until the time of surgical repair or death due to rupture of AAA or other causes. |
| Open Surgical Repair Patients | – | Device: Resoundant Driver SystemFifty to sixty five patients patients undergoing open surgical repair will be recruited and undergo MRE (with Resoundant driver system) prior to surgery |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Normal volunteers are control group 2. Patients who are being monitored for diameter of AAA 3. Patients who will undergo surgical repair of AAA
Key inclusion criteria (2 listed)
- Must be able to lie flat on their back in the scanner for up to 60 minutes
- Must be able to hold breath for up to 15 seconds
Key exclusion criteria (3 listed)
- Patients who are claustrophobic
- Patients who are pregnant
- Patients with any unapproved, non-MRI save metal/devices in or on their body
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 |
|---|---|---|
| Resoundant Driver SystemAlso: DriverThis device is used to generate vibrations at the area of interest. The device has an active driver, a loud speaker sitting outside the scanner area, and a passive driver, which is shaped like a silicone paddle, which is secured with velcro straps to the area being imaged. Sound waves from the active driver travel through a tube attached to the passive driver and generate vibrations, images of which are captured by the MR scanner. | Device | Normal Volunteers, Open Surgical Repair Patients, Patients with AAA |
Primary outcome
MRE-Derived Shear Stiffness in kPa
Time frame: Upto 36 months at every 6 months
Use of MRE stiffness estimates to determine rupture
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
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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.
Arunark Kolipaka, PhD principal investigator
The Ohio State University Medical Center Dept. of Radiology
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 Abdominal Aortic Aneurysm, run by Ohio State University 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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 21 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristin L Thompson, B.S. (614-366-5429, Kristin.Thompson@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRE-Derived Shear Stiffness in kPa (time frame: Upto 36 months at every 6 months). 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 21 Oct 2026.