Skip to content

Advanced MRI in AAA

Advanced MRI in AAA

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03138434
Enrollment
31
Registered
2017-05-03
Start date
2017-04-12
Completion date
2019-05-29
Last updated
2019-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Aortic Aneurysm

Keywords

Abdominal Aortic Aneurysm, 4D flow MRI, DCE-MRI, T1 and T2 mapping

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

Interventions

None listed

Sponsors

Ron Balm
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Wall shear stress (WSS)Time of MRI scanPrimary outcome of 4D flow MRI
Kinetic transport constant (Ktrans)Time of MRI scanPrimary outcome of DCE-MRI
T1 relaxation timeTime of MRI scanPrimary outcome of T1 mapping
T2 relaxation timeTime of MRI scanPrimary outcome of T2 mapping

Secondary

MeasureTime frameDescription
Wash-in slopeTime of MRI scanSecondary outcome of DCE-MRI
Peak flow velocity inside the aneurysmTime of MRI scanSecondary outcome of 4D flow MRI
Location of peak wall shear stressTime of MRI scanSecondary outcome of 4D flow MRI
Time to peak (TTP)Time of MRI scanSecondary outcome of DCE-MRI
Flow patternsTime of MRI scanSecondary outcome of 4D flow MRI
Oscillatory shear indexTime of MRI scanSecondary outcome of 4D flow MRI
Reverse reflux rate constant (kep)Time of MRI scanSecondary outcome of DCE-MRI
Flow velocity at aneurysm entranceTime of MRI scanSecondary outcome of 4D flow MRI
Mean transit time (MTT)Time of MRI scanSecondary outcome of DCE-MRI
Area under the curve of contrast uptakeTime of MRI scanSecondary outcome of DCE-MRI
Peak enhancement ratioTime of MRI scanSecondary outcome of DCE-MRI

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026