Magnetic Resonance Elastography in Patients With Abdominal Aortic Aneurysms

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Abdominal aortic aneurysm
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Cook – Abdominal aortic aneurysm Cordis Corporation – Abdominal Aortic Aneurysm
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Brief Title

Magnetic Resonance Elastography in Patients With Abdominal Aortic Aneurysms

Official Title

Magnetic Resonance Elastography in Patients With Abdominal Aortic Aneurysms

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.

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 Type

Observational

Primary Outcome

MRE-Derived Shear Stiffness in kPa

Condition

Abdominal Aortic Aneurysm

Intervention

Resoundant Driver System

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Device

Estimated Enrollment

165

Start Date

October 2014

Completion Date

October 2020

Primary Completion Date

October 2020

Eligibility Criteria

        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

Gender

All

Ages

20 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Arunark Kolipaka, PhD, 614-366-5429, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT02387255

Organization ID

2013H0416

Responsible Party

Principal Investigator

Study Sponsor

Ohio State University

Study Sponsor

Arunark Kolipaka, PhD, Principal Investigator, The Ohio State University Medical Center Dept. of Radiology

Verification Date

September 2020