Advanced MRI in AAA

Ron Balm

Status: Terminated

Conditions: Abdominal Aortic Aneurysm

Study type: Observational

Funder types: Other

Identifiers

NCT03138434

NL56823.018.16

Details and patient eligibility

About

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.

Full 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

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

31 participants in 2 patient groups

Optimization phase

Description:

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.

Study phase

Description:

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.