Predicting Aneurysm Growth and Rupture With Longitudinal Biomarkers

Study Overview
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Brief Summary
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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
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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

Official Title
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Predicting Aneurysm Growth and Rupture With Longitudinal Biomarkers (PARIS Study) & Biobank Pearl AAA

Conditions
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Abdominal Aortic Aneurysm, Abdominal Aortic Aneurysm, Ruptured

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Asymptomatic AAA<br>These patients will be included while their AAA is asymptomatic and while they are under surveillance by their vascular surgeon. | |
| Acute AAA<br>These are the patients that are included while they presented in the participating hospitals because either a symptomatic or ruptured AAA. For this group, a different recruitment procedure exists which has been approved by the appropriate medical ethical committee. | |
| Repaired AAA<br>These patients are included while they already had had AAA repair (both elective and emergency repair). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AAA growth | Growth of abdominal aortic aneurysm, measured on imaging made for clinical purposes | Up to 10 years of follow-up | 
| AAA rupture | Rupture of an abdominal aortic aneurysm | Up to 10 years of follow-up | 
| Death | All-cause mortality | Up to 10 years of follow-up | 
| Evolution of serum levels of proteases | Repeated measurements analysis of serum levels of proteases in cohort of asymptomatic AAAs | a maximum of 1 measurement annually up to 10 years of follow-up | 
| Evolution of serum levels of cytokines | Repeated measurements analysis of serum levels of cytokines in cohort of asymptomatic AAAs | a maximum of 1 measurement annually up to 10 years of follow-up | 
| Protease levels in aortic tissue | 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. | 
| Cytokine levels in aortic tissue | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type of complications after AAA repair | 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 | Will be measured up to 10 years after AAA repair is performed | 
| Incidence of complications after AAA repair | Number of complications after abdominal aortic aneurysm repair | Will be measured up to 10 years after AAA repair is performed | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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biobank, pathogenesis, Aortic Aneurysm