Primary Objectives: •To determine the correlation between AAA growth and the evolution of serum levels of proteases and cytokines.•To determine the correlation between AAA rupture and the evolution of serum levels of proteases and cytokines.•To…
ID
Source
Brief title
Condition
- Aneurysms and artery dissections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameters/outcomes
•AAA growth (mm/y). This will be measured using repeated imaging with either
ultrasound, CT or MRI.
•AAA rupture. This is defined as acute haemorrhage from the aneurysm outside
the true aortic wall with the presence of intra-peritoneal and/or
retroperitoneal blood at imaging, or observed during repair.
•Death
•Serum levels of cytokines (including, but not limited to IL- 6)
•Serum levels of proteases (including, but not limited to MMP-9)
•Protease and cytokine levels in aortic tissue
Secondary outcome
Secondary study parameters/outcomes
•During the course of the study, additional study parameters will be collected,
as part of regular clinical care. For a full overview of all study parameters
collected, please see the clinical data items titled PRISMA. PRISMA will
contain all parameters collected during this project. Due to the longitudinal
nature of this project, PRISMA may be subject to change.
•Incidence of complications after AAA repair
•Type of complications after AAA repair
Background summary
Abdominal aortic aneurysms (AAAs) are local dilatations of the abdominal aorta.
They are generally asymptomatic, but can grow or eventually rupture. AAA
rupture is associated with high morbidity and mortality. Therefore, current
treatment is to prevent rupture through aneurysm repair. The decision to carry
out this repair is based on aneurysm diameter, since aneurysm with a larger
diameter have a higher rupture risk. However, aneurysm diameter is not a very
reliable predictor of rupture. Therefore, further research has focused on
elucidating the pathogenesis of aneurysm progression in order to identify
additional predictors of growth and rupture.
Study objective
Primary Objectives:
•To determine the correlation between AAA growth and the evolution of serum
levels of proteases and cytokines.
•To determine the correlation between AAA rupture and the evolution of serum
levels of proteases and cytokines.
•To determine the correlation between overall survival and the evolution of
serum levels of proteases and cytokines.
•To determine the correlation between serum levels of proteases and cytokines
and levels of proteases and cytokines in aortic tissue.
Secondary Objectives:
•To create a new biobanking infrastructure that will enable future research
initiatives focusing on the identification of other factors involved in AAA
pathogenesis. Additional biomaterials, images and clinical data will be
collected in extension of this study; in a biobank, imagebank and databank,
respectively.
•To determine the incidence of complications after AAA repair.
•To characterize the complications after AAA repair.
Study design
A prospective multicentre observational cohort study
Study burden and risks
There is no direct benefit for the participants. This is a longitudinal study
in which patients will be followed-up for many years, for as long as their AAA
treatment is continued. This may mean that a participant is followed-up for
life. In addition to the regular clinical treatment, biomaterials, imaging data
and clinical data will be collected and saved. The biomaterials consist of
venous blood and urine. Also, in the few cases where conventional open surgery
is indicated, AAA tissue samples will be collected. Collection of AAA tissue is
without risks. The frequency of biomaterial collection will be in accordance to
the frequency of regular clinical hospital visits. The imaging data will
consist of CT and MRI images that have been generated as part of regular
clinical practice. Clinical data will be obtained during regular patient visits
to the hospital.
Some of the patients will be included while they are decisionally impaired due
to the effects of an acute AAA. These patients represent an important clinical
outcome in the natural history of AAA and are therefore included. Such
information cannot be learned from patients who do not have an acute AAA. The
risks and burden while a patient is decisionally impaired is minimal. To
instigate treatment of these patients, venous blood will already be drawn for
clinical diagnosis and all patients get a urinary catheter to prevent urinary
retention during treatment.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL59991.018.17 |