An observational study in Abdominal Aortic Aneurysm, sponsored by Ron Balm. Terminated at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-05.
Sponsored by Ron Balm · Observational
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.
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:
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
Adult patients with an abdominal aortic aneurysms who are patients at the department of vascular surgery of the Academic Medical Center.
Exclusion Criteria:
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.
This phase will commence after the optimization phase. This phase is where we want to assess the feasibility, reproducibility and association with disease severity between MRI parameters and AAA. These twenty patients will be scanned twice, with an interval of 1 week ± 5 days. The study will be completed when we have 20 patients with 2 scans for each sequence, or when a maximum number of 30 patients in the study phase have been scanned.
Wall shear stress (WSS)
Primary outcome of 4D flow MRI
Time frame: Time of MRI scan
Kinetic transport constant (Ktrans)
Primary outcome of DCE-MRI
Time frame: Time of MRI scan
T1 relaxation time
Primary outcome of T1 mapping
Time frame: Time of MRI scan
T2 relaxation time
Primary outcome of T2 mapping
Time frame: Time of MRI scan
Peak flow velocity inside the aneurysm
Secondary outcome of 4D flow MRI
Time frame: Time of MRI scan
Location of peak wall shear stress
Secondary outcome of 4D flow MRI
Time frame: Time of MRI scan
Flow velocity at aneurysm entrance
Secondary outcome of 4D flow MRI
Time frame: Time of MRI scan
Flow patterns
Secondary outcome of 4D flow MRI
Time frame: Time of MRI scan
Oscillatory shear index
Secondary outcome of 4D flow MRI
Time frame: Time of MRI scan
Reverse reflux rate constant (kep)
Secondary outcome of DCE-MRI
Time frame: Time of MRI scan
Area under the curve of contrast uptake
Secondary outcome of DCE-MRI
Time frame: Time of MRI scan
Peak enhancement ratio
Secondary outcome of DCE-MRI
Time frame: Time of MRI scan
Wash-in slope
Secondary outcome of DCE-MRI
Time frame: Time of MRI scan
Time to peak (TTP)
Secondary outcome of DCE-MRI
Time frame: Time of MRI scan
Mean transit time (MTT)
Secondary outcome of DCE-MRI
Time frame: Time of MRI scan
Plan to share: Undecided
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This study is terminated, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Ron Balm