MRI molecular imaging of (inflammatory) macrophages as a predictor of abdominal aortic aneurysm progressio

Recruiting

Conditions: AAA
Aneurysm
10002363

Registration Number: NL-OMON32371

Lead Sponsor: Academisch Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 80

Inclusion Criteria

For phase 1: all patients with an AAA which are eligable for surgical repair. For phase 2: all patients with an AAA with a diameter between 30 and 50 mm which are under surveillance at our hospital.

Exclusion Criteria

Patients with clinical inflammatory AAA and/or other inflammatory disorders. Patients with contraindications for MR scanning, including a pacemaker, metal objects in the eye, middle ear implants, implanted pumps or neurostimulators. And relative contraindications for MR scanning: metal cardiac valve, intracranial clips/coils for aneurysm, vena cava filter and metal prosthesis. Patients with contraindication for contrast enhanced CT, including those with a previous anaphylactic response to the contrast medium and patients with diminished kidney function as reflected by a serum creatinine of >130 µmol/l.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the change in relative decrease of the post USPIO<br /><br>MR signal between different follow up moments. This relative signal loss will<br /><br>be related to the maximal aortic diameter change between different follow up<br /><br>moments.<br /><br>The main objective of our study is to differentiate between patients with<br /><br>stable or slowly growing AAA from<br /><br>patients with rapidly growing AAA. We believe that inflammation is a major<br /><br>player in the process of growth. In order to achieve our main objective we need<br /><br>to relate the individual degree and distribution of the inflammation of the AAA<br /><br>wall to specific growth rate and patterns. Inflammation will be visualized by<br /><br>means of USPIO-enhanced MR.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary objectives are to associate the degree and distribution of the<br /><br>inflammation of the abdominal aortic<br /><br>wall of patients with AAA with (i) systemic markers of inflammation, and (ii)<br /><br>the distribution of the wall stress.</p><br>