PARIS: Predicting Aneurysm Growth and Rupture With Longitudinal Biomarkers

Sponsor

Ron Balm (Other)

Overall Status

Recruiting

CT.gov ID

NCT03320408

Collaborator

Parelsnoer Institute the Netherlands (Other)

750

Enrollment

Locations

180

Anticipated Duration (Months)

375

Patients Per Site

2.1

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Abdominal Aortic Aneurysm Abdominal Aortic Aneurysm, Ruptured

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

750 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 4, 2017

Anticipated Primary Completion Date :

Oct 4, 2032

Anticipated Study Completion Date :

Oct 4, 2032

Arms and Interventions

Arm	Intervention/Treatment
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).

Outcome Measures

Primary Outcome Measures

AAA growth [Up to 10 years of follow-up]
Growth of abdominal aortic aneurysm, measured on imaging made for clinical purposes
AAA rupture [Up to 10 years of follow-up]
Rupture of an abdominal aortic aneurysm
Death [Up to 10 years of follow-up]
All-cause mortality
Evolution of serum levels of proteases [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
Evolution of serum levels of cytokines [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
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.]
Protease 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.]
Cytokine levels in aortic tissue

Secondary Outcome Measures

Type of complications after AAA repair [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
Incidence of complications after AAA repair [Will be measured up to 10 years after AAA repair is performed]
Number of complications after abdominal aortic aneurysm repair

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Leiden University Medical Center (LUMC)	Leiden	Zuid-Holland	Netherlands	2333ZA
2	Department of Vascular Surgery, Amsterdam UMC, location AMC	Amsterdam		Netherlands	1105 AZ