Trials / Terminated
TerminatedNCT03138434
Advanced MRI in AAA
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 31 (actual)
- Sponsor
- Ron Balm · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Conditions
Timeline
- Start date
- 2017-04-12
- Primary completion
- 2019-05-29
- Completion
- 2019-05-29
- First posted
- 2017-05-03
- Last updated
- 2019-07-05
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT03138434. Inclusion in this directory is not an endorsement.