Advanced MRI in AAA
- Conditions
- Abdominal Aortic Aneurysm
- Registration Number
- NCT03138434
- Lead Sponsor
- Ron Balm
- 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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 31
- Adult patients (≥ 18 years of age)
- Abdominal aortic aneurysm with a maximal aneurysm diameter of at least 30 mm
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Wall shear stress (WSS) Time of MRI scan Primary outcome of 4D flow MRI
T1 relaxation time Time of MRI scan Primary outcome of T1 mapping
Kinetic transport constant (Ktrans) Time of MRI scan Primary outcome of DCE-MRI
T2 relaxation time Time of MRI scan Primary outcome of T2 mapping
- Secondary Outcome Measures
Name Time Method Wash-in slope Time of MRI scan Secondary outcome of DCE-MRI
Peak flow velocity inside the aneurysm Time of MRI scan Secondary outcome of 4D flow MRI
Location of peak wall shear stress Time of MRI scan Secondary outcome of 4D flow MRI
Peak enhancement ratio Time of MRI scan Secondary outcome of DCE-MRI
Flow velocity at aneurysm entrance Time of MRI scan Secondary outcome of 4D flow MRI
Oscillatory shear index Time of MRI scan Secondary outcome of 4D flow MRI
Reverse reflux rate constant (kep) Time of MRI scan Secondary outcome of DCE-MRI
Mean transit time (MTT) Time of MRI scan Secondary outcome of DCE-MRI
Flow patterns Time of MRI scan Secondary outcome of 4D flow MRI
Area under the curve of contrast uptake Time of MRI scan Secondary outcome of DCE-MRI
Time to peak (TTP) Time of MRI scan Secondary outcome of DCE-MRI
Trial Locations
- Locations (1)
Department of Vascular Surgery
🇳🇱Amsterdam, Netherlands