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Completed

NCT Number: NCT03320408

Predicting Aneurysm Growth and Rupture With Longitudinal Biomarkers

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

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Key information

Conditions

Abdominal Aortic Aneurysm Abdominal Aortic Aneurysm, Ruptured Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Aortic Diseases Cardiovascular Diseases Rupture Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Leiden University Medical Center (LUMC), Leiden, South Holland, Netherlands

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. AAA growth

    Time frame: Up to 10 years of follow-up

    Growth of abdominal aortic aneurysm, measured on imaging made for clinical purposes

  2. AAA rupture

    Time frame: Up to 10 years of follow-up

    Rupture of an abdominal aortic aneurysm

  3. Death

    Time frame: Up to 10 years of follow-up

    All-cause mortality

  4. Evolution of serum levels of proteases

    Time frame: 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

  5. Evolution of serum levels of cytokines

    Time frame: 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

  6. Protease levels in aortic tissue

    Time frame: 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

  7. Cytokine levels in aortic tissue

    Time frame: 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

Secondary outcomes

  1. Type of complications after AAA repair

    Time frame: 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

  2. Incidence of complications after AAA repair

    Time frame: Will be measured up to 10 years after AAA repair is performed

    Number of complications after abdominal aortic aneurysm repair

Sponsors and collaborators

Lead sponsor

Ron Balm

Other

Registry information

Official study title

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

Acronym: PARIS

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Oct 25, 2017
Registry last updated
Aug 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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