Predicting Aneurysm Growth and Rupture With Longitudinal Biomarkers

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Abdominal aortic aneurysm
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Cook – Abdominal aortic aneurysm Cordis Corporation – Abdominal Aortic Aneurysm
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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