Advanced MRI in AAA

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Abdominal aortic aneurysm
Related Access Program
Cook – Abdominal aortic aneurysm Cordis Corporation – Abdominal Aortic Aneurysm
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Brief Title

Advanced MRI in AAA

Official Title

Advanced MRI in AAA

Brief Summary

      This study aims to determine whether advanced MRI sequences can provide robust and clinically
      relevant information about abdominal aortic aneurysms (AAAs). The MRI sequences will study
      outcomes related to blood flow inside AAA, microvasculature of the AAA vessel wall and
      intraluminal thrombus inside AAA.

      Robustness of these MRI sequences will be determined with testing of feasibility and
      reproducibility. Clinical relevance will be assessed by studying the association between the
      primary outcomes and disease severity. Disease severity will be expressed by AAA diameter.

      It is our hypothesis that these parameters are significantly related to disease severity and
      may therefore be future markers of disease progression.

Detailed Description

      This prospective study evaluates the feasibility, reproducibility and clinical relevance of
      MRI sequences in adults with an abdominal aortic aneurysm (AAA).

      The MRI sequences and their primary outcomes are:

        -  Four-dimensional (4D) flow MRI and wall shear stress (WSS)

        -  Dynamic Contrast-Enhanced (DCE) MRI and kinetic transport constant (Ktrans)

        -  T1 and T2 mapping (T1 and T2 relaxation times)

      Feasibility is tested by the production of high-quality images that enable calculation of the
      primary outcomes. Reproducibility is tested by calculating interscan, intra- and
      interobserver variability. Clinical relevance is tested by assessing the association between
      primary outcomes and disease severity which is expressed by AAA diameter

Study Type

Observational

Primary Outcome

Wall shear stress (WSS)

Secondary Outcome

 Peak flow velocity inside the aneurysm

Condition

Abdominal Aortic Aneurysm

Study Arms / Comparison Groups

 Optimization phase
Description:  The first five patients will be included for the optimization of the MRI sequences. This is to ensure that a standard protocol will work for different sizes of AAA. These patients will only be scanned once.

Publications

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

Recruitment Information

Estimated Enrollment

31

Start Date

April 12, 2017

Completion Date

May 29, 2019

Primary Completion Date

May 29, 2019

Eligibility Criteria

        Inclusion Criteria:

          -  Adult patients (≥ 18 years of age)

          -  Abdominal aortic aneurysm with a maximal aneurysm diameter of at least 30 mm

        Exclusion Criteria:

          -  Contra-indications for MRI

          -  Severely reduced renal function (eGFR < 30)

          -  Previous allergic reaction to intravenous contrast agents

          -  Suprarenal AAA

          -  Pararenal AAA

          -  Previous aneurysm repair

          -  Inflammatory aneurysm

          -  Mycotic or other infectious aneurysm

          -  Vasculitis

          -  Connective tissue disease

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Ron Balm, MD PhD, ,

Location Countries

Netherlands

Location Countries

Netherlands

Administrative Informations

NCT ID

NCT03138434

Organization ID

NL56823.018.16

Responsible Party

Sponsor-Investigator

Study Sponsor

Ron Balm

Study Sponsor

Ron Balm, MD PhD, Principal Investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Verification Date

July 2019