Recruiting

Observational Study

Sponsor:

Ohio State University

Code:

NCT02387255

Conditions

Abdominal Aortic Aneurysm

Eligibility Criteria

Sex: All

Age: 20+

Healthy Volunteers: Accepted

Interventions

Resoundant Driver System

Study Details

Brief 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 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.

Conditions

Abdominal Aortic Aneurysm

Study ID

NCT02387255

Start date

Oct, 2014

Status verified date

Apr, 2025

Completion date

Oct 31, 2028

Anticipated

Primary completion date

Oct 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients who are claustrophobic
  • Patients who are pregnant
  • Patients with any unapproved, non-MRI save metal/devices in or on their body

Study Design

Enrollment

165 participants

Anticipated

Interventions and Outcome Measures

Arms

Normal Volunteers

60 normal volunteers will be recruited. Each volunteer will undergo a single MRE scan (with Resoundant driver System ) of their abdominal aorta.

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.

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

Interventions

Resoundant Driver System

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.

Primary outcome measure

  • MRE-Derived Shear Stiffness in kPa [ Time Frame: Upto 36 months at every 6 months ]

Central Contacts and Locations

Central contacts

Kristin L Thompson, B.S.

614-366-5429Kristin.Thompson@osumc.edu

Locations

The Ohio State University Medical Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Kristin L Thompson, B.S.

614-366-5429Kristin.Thompson@osumc.edu

Principal Investigator:

Arunark Kolipaka, PhD

More Information

Sponsor

Ohio State University

Last update posted

Apr 8, 2025

Last verified

Apr, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University on 2025-04-08.