Predicting Aneurysm Growth & Rupture With Longitudinal Biomarkers

Status Completed

Clinical Trial 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

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03320408
Study type	Observational [Patient Registry]
Source	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Contact
Status	Completed
Phase
Start date	October 4, 2017
Completion date	August 4, 2023

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Predicting Aneurysm Growth and Rupture With Longitudinal Biomarkers — PARIS

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms