Abdominal Aortic Aneurysm, Abdominal Aortic Aneurysm, Ruptured
Conditions
Keywords
biobank, pathogenesis, Aortic Aneurysm
Brief summary
First aim: PARIS study The main aim of the current study is to determine the association between abdominal aortic aneurysm (AAA) progression and the evolution of proteases and cytokines levels.To achieve this aim, we will prospectively collect blood, aortic tissue, patient data, and imaging data. Aortic tissue will only be obtained when patients undergo conventional open repair. The other biomaterials will be collected during regular patient follow-up visits, with a maximum frequency of once per year. Second aim: Pearl AAA biobank For future research purposes, a new biobanking infrastructure will be created to collect and store additional blood and urine samples in a biobank. This biobank will be embedded within the infrastructure of the 'Parelsnoer Institute' (PSI) and will be called Pearl AAA. The Pearl AAA will be established in the extension of the PARIS study
Detailed description
The PARIS study aims to determine the correlation between AAA progression (growth or rupture) and the evolution of serum levels of proteases and cytokines over time. A repeated measures analysis will be done to use all longitudinal data available. The Pearl AAA biobank will be established to enable the PARIS study, but also aims to facilitate future research. Such future research should fall under the scientific aims of the Pearl AAA, which are: * To gain insight in the pathogenesis of AAA * To gain more knowledge in the rupture risk of AAA * To evaluate and potentially improve treatment of AAA The 'Parelsnoer Institute' will facilitate the biobank Pearl AAA with certain aspects such as, but not limited to the following: * Standardized operating procedures for the collection and storage of the biosamples across all participating hospitals * Information architect to establish a data dictionary in which all variables are defined * Standardized procedures for coding of patient data before storage * Standardized digital infrastructure to enhance storage of patient data and imaging data
Interventions
None listed
Sponsors
Ron Balm
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult participant (18 years or older) * Participant has an AAA or has previously been treated for an AAA * 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 the patients who are decisionally impaired due to the effects of an acute AAA. This particular group is eligible for which a separate recruitment and consent procedure exists.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cytokine levels in aortic tissue | If open AAA repair is performed and aortic tissue is collected, cytokine levels will then be measured. This is a one-time measurement. | Cytokine levels in aortic tissue |
| Evolution of serum levels of cytokines | a maximum of 1 measurement annually up to 10 years of follow-up | Repeated measurements analysis of serum levels of cytokines in cohort of asymptomatic AAAs |
| Protease levels in aortic tissue | If open AAA repair is performed and aortic tissue is collected, protease levels will then be measured. This is a one-time measurement. | Protease levels in aortic tissue |
| AAA growth | Up to 10 years of follow-up | Growth of abdominal aortic aneurysm, measured on imaging made for clinical purposes |
| AAA rupture | Up to 10 years of follow-up | Rupture of an abdominal aortic aneurysm |
| Death | Up to 10 years of follow-up | All-cause mortality |
| Evolution of serum levels of proteases | a maximum of 1 measurement annually up to 10 years of follow-up | Repeated measurements analysis of serum levels of proteases in cohort of asymptomatic AAAs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of complications after AAA repair | Will be measured up to 10 years after AAA repair is performed | Number of complications after abdominal aortic aneurysm repair |
| Type of complications after AAA repair | Will be measured up to 10 years after AAA repair is performed | Type of complications using methodology from the Dutch committee of the Nederlandse Vereniging voor Heelkunde, named the Landelijke Heelkunde Complicatie Registratie as found on www.lhcr.nl |
Countries
Netherlands
Outcome results
None listed