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NCT Number: NCT02387255

Magnetic Resonance Elastography in Patients With Abdominal Aortic Aneurysms

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location status: Recruiting

Location contact

Arunark Kolipaka, PhD

PRINCIPAL_INVESTIGATOR

Kristin L Thompson, B.S.

CONTACT

[email protected]

614-366-5429

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Driver

Primary outcomes

  1. MRE-Derived Shear Stiffness in kPa

    Time frame: Upto 36 months at every 6 months

    Use of MRE stiffness estimates to determine rupture

Study contacts

Contact information is provided by the study sponsor or research team.

Kristin L Thompson, B.S.

CONTACT

[email protected]

614-366-5429

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Acronym: AAA-MRE

Important dates

Study start
2014
Primary completion
2028
Study completion
2028
First posted
Mar 12, 2015
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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