Predicting aneurysm growth and rupture with longitudinal biomarkers

Recruiting

Conditions: Abdominal aortic aneurysm
local enlargement of the main abdominal artery
10002363

Registration Number: NL-OMON49399

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 750

Inclusion Criteria

- Adult person (18 years or older)
- Person has an abdominal aortic aneurysm or has previously been treated for an
abdominal aortic aneurysm
- Adequate comprehension of the Dutch language to provide written informed
consent

Exclusion Criteria

- A patient who is decisionally impaired. The only exception to this are
patients who are decisionally impaired due to effects of an acute abdominal
aortic aneurysm. This particular group is eligible for participation

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary study parameters/outcomes<br /><br>•AAA growth (mm/y). This will be measured using repeated imaging with either<br /><br>ultrasound, CT or MRI.<br /><br>•AAA rupture. This is defined as acute haemorrhage from the aneurysm outside<br /><br>the true aortic wall with the presence of intra-peritoneal and/or<br /><br>retroperitoneal blood at imaging, or observed during repair.<br /><br>•Death<br /><br>•Serum levels of cytokines (including, but not limited to IL- 6)<br /><br>•Serum levels of proteases (including, but not limited to MMP-9)<br /><br>•Protease and cytokine levels in aortic tissue</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters/outcomes<br /><br>•During the course of the study, additional study parameters will be collected,<br /><br>as part of regular clinical care. For a full overview of all study parameters<br /><br>collected, please see the clinical data items titled PRISMA. PRISMA will<br /><br>contain all parameters collected during this project. Due to the longitudinal<br /><br>nature of this project, PRISMA may be subject to change.<br /><br>•Incidence of complications after AAA repair<br /><br>•Type of complications after AAA repair</p><br>