Predicting Aneurysm Growth and Rupture With Longitudinal Biomarkers (PARIS)

August 18, 2023 updated by: Ron Balm

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

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

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

790

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Department of Vascular Surgery, Amsterdam UMC, location AMC
    • Zuid-Holland
      • Leiden, Zuid-Holland, Netherlands, 2333ZA
        • Leiden University Medical Center (LUMC)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

All adult patients with an abdominal aortic aneurysm who present themselves in the participating hospitals.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Asymptomatic AAA
These patients will be included while their AAA is asymptomatic and while they are under surveillance by their vascular surgeon.
Acute AAA
These are the patients that are included while they presented in the participating hospitals because either a symptomatic or ruptured AAA. For this group, a different recruitment procedure exists which has been approved by the appropriate medical ethical committee.
Repaired AAA
These patients are included while they already had had AAA repair (both elective and emergency repair).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AAA growth
Time Frame: Up to 10 years of follow-up
Growth of abdominal aortic aneurysm, measured on imaging made for clinical purposes
Up to 10 years of follow-up
AAA rupture
Time Frame: Up to 10 years of follow-up
Rupture of an abdominal aortic aneurysm
Up to 10 years of follow-up
Death
Time Frame: Up to 10 years of follow-up
All-cause mortality
Up to 10 years of follow-up
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
a maximum of 1 measurement annually up to 10 years of follow-up
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
a maximum of 1 measurement annually up to 10 years of follow-up
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
If open AAA repair is performed and aortic tissue is collected, protease levels will then be measured. This is a one-time measurement.
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
If open AAA repair is performed and aortic tissue is collected, cytokine levels will then be measured. This is a one-time measurement.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Will be measured up to 10 years after AAA repair is performed
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
Will be measured up to 10 years after AAA repair is performed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ron Balm

Collaborators

Parelsnoer Institute the Netherlands

Investigators

  • Principal Investigator: Ron Balm, MD PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2017

Primary Completion (Actual)

August 4, 2023

Study Completion (Actual)

August 4, 2023

Study Registration Dates

First Submitted

October 12, 2017

First Submitted That Met QC Criteria

October 23, 2017

First Posted (Actual)

October 25, 2017

Study Record Updates

Last Update Posted (Actual)

August 22, 2023

Last Update Submitted That Met QC Criteria

August 18, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL59991.018.17
  • Biobank Pearl AAA (Registry Identifier: Biobank Pearl AAA)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Researchers can initiate the procedure to request IPD for research that falls within the scientific scope of the biobank Pearl AAA.

IPD Sharing Time Frame

Depending on the specific study protocols that are submitted to the biobank Pearl AAA

IPD Sharing Access Criteria

Procedural criteria can be attained by contacting the researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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