Clinical Trials Directory

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.