NCT03320408

Predicting Aneurysm Growth and Rupture With Longitudinal Biomarkers

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 790 (actual)
• Sponsor: Ron Balm · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Abdominal Aortic Aneurysm
• Abdominal Aortic Aneurysm, Ruptured

Timeline

• Start date: 2017-10-04
• Primary completion: 2023-08-04
• Completion: 2023-08-04
• First posted: 2017-10-25
• Last updated: 2023-08-22

Locations

2 sites across 1 country: Netherlands