Brief Title
Predicting Aneurysm Growth and Rupture With Longitudinal Biomarkers
Official Title
Predicting Aneurysm Growth and Rupture With Longitudinal Biomarkers (PARIS Study) & Biobank Pearl AAA
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 Type
Observational [Patient Registry]
Primary Outcome
AAA growth
Secondary Outcome
Type of complications after AAA repair
Condition
Abdominal Aortic Aneurysm
Study Arms / Comparison Groups
Asymptomatic AAA
Description: These patients will be included while their AAA is asymptomatic and while they are under surveillance by their vascular surgeon.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
750
Start Date
October 4, 2017
Completion Date
October 4, 2032
Primary Completion Date
October 4, 2032
Eligibility Criteria
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Ron Balm, MD PhD, +31205663405, [email protected]
Location Countries
Netherlands
Location Countries
Netherlands
Administrative Informations
NCT ID
NCT03320408
Organization ID
NL59991.018.17
Secondary IDs
Biobank Pearl AAA
Responsible Party
Sponsor-Investigator
Study Sponsor
Ron Balm
Collaborators
Parelsnoer Institute the Netherlands
Study Sponsor
Ron Balm, MD PhD, Principal Investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Verification Date
February 2022