Predicting Aneurysm Growth and Rupture With Longitudinal Biomarkers

Abdominal Aortic Aneurysm Clinical Trial

— PARIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03320408
• Other study ID #: NL59991.018.17
• Secondary ID: Biobank Pearl AA
• Status: Completed
• Start date: October 4, 2017
• Est. completion date: August 4, 2023

Study information

• Verified date: August 2023
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 790
• Est. completion date: August 4, 2023
• Est. primary completion date: August 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Abdominal Aortic Aneurysm, Ruptured
• Aneurysm
• Aneurysm, Ruptured
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Aortic Rupture
• Rupture

Locations

Country	Name	City	State
Netherlands	Department of Vascular Surgery, Amsterdam UMC, location AMC	Amsterdam
Netherlands	Leiden University Medical Center (LUMC)	Leiden	Zuid-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Ron Balm

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AAA growth	Growth of abdominal aortic aneurysm, measured on imaging made for clinical purposes	Up to 10 years of follow-up
Primary	AAA rupture	Rupture of an abdominal aortic aneurysm	Up to 10 years of follow-up
Primary	Death	All-cause mortality	Up to 10 years of follow-up
Primary	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
Primary	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
Primary	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.
Primary	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	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
Secondary	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