Magnetic Resonance Elastography in Patients With Abdominal Aortic Aneurysms

NCT02387255 | Recruiting

• 1 other identifier: 2013H0416
• Study Type: observational
• Target: 165
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• MRE-Derived Shear Stiffness in kPa

  Use of MRE stiffness estimates to determine rupture

  Upto 36 months at every 6 months

Study Arms (3)

Normal Volunteers

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

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.

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

Device: Resoundant Driver System

Interventions

Resoundant Driver System DEVICE

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.

Also known as: Driver

Normal Volunteers; Open Surgical Repair Patients; Patients with AAA

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

We will collect a small aortic tissue sample for biomechanical testing from patients undergoing standard of care surgical repair of their abdominal aortic aneurysm.

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Arunark Kolipaka, PhD

  The Ohio State University Medical Center Dept. of Radiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristin L Thompson, B.S.

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 19, 2015
• First Posted: March 12, 2015
• Study Start: October 1, 2014
• Primary Completion (Estimated): October 31, 2028
• Study Completion (Estimated): October 31, 2028
• Last Updated: April 8, 2025

Record last verified: 2025-04

Locations

US (1)