Predicting Aneurysm Growth and Rupture With Longitudinal Biomarkers (PARIS)

Ron Balm

Status: Completed

Conditions: Abdominal Aortic Aneurysm; Abdominal Aortic Aneurysm, Ruptured

Study type: Observational

Funder types: Other

Identifiers

NCT03320408

Biobank Pearl AAA (Registry Identifier)

NL59991.018.17

Details and patient eligibility

About

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

Full 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

Enrollment: 790 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

790 participants in 3 patient groups

Asymptomatic AAA

Description:

These patients will be included while their AAA is asymptomatic and while they are under surveillance by their vascular surgeon.

Acute AAA

Description:

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

Description:

These patients are included while they already had had AAA repair (both elective and emergency repair).