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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03320408
Other study ID # NL59991.018.17
Secondary ID Biobank Pearl AA
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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