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