Predicting Aneurysm Growth and Rupture With Longitudinal Biomarkers

Completed

• Conditions: Abdominal Aortic Aneurysm, Ruptured; Abdominal Aortic Aneurysm

• Registration Number: NCT03320408
• Lead Sponsor: Ron Balm

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

Study Timeline

• Study Start: 2017-10-04
• Study First Submitted: 2017-10-12
• Study First Submitted QC: 2017-10-23
• Study First Posted: 2017-10-25
• Status Verified: 2023-08
• Primary Completion: 2023-08-04
• Study Completion: 2023-08-04
• Last Update Submitted: 2023-08-18
• Last Update Posted: 2023-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 790

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
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
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
AAA rupture	Up to 10 years of follow-up	Rupture of an abdominal aortic aneurysm
AAA growth	Up to 10 years of follow-up	Growth of abdominal aortic aneurysm, measured on imaging made for clinical purposes
Death	Up to 10 years of follow-up	All-cause mortality

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (2)

Leiden University Medical Center (LUMC); 🇳🇱 Leiden, Zuid-Holland, Netherlands

Department of Vascular Surgery, Amsterdam UMC, location AMC; 🇳🇱 Amsterdam, Netherlands