Clinical trial NCT03320408: Predicting Aneurysm Growth and Rupture With Longitudinal Biomarkers
Official title: Predicting Aneurysm Growth and Rupture With Longitudinal Biomarkers (PARIS Study) & Biobank Pearl AAA
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abdominal Aortic Aneurysm
Abdominal Aortic Aneurysm, Ruptured
Keywords: biobank
pathogenesis
Aortic Aneurysm
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2017-10-25
Enrollment: 790
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All adult patients with an abdominal aortic aneurysm who present themselves in the participating hospitals.

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

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.

Primary outcomes:
measure: AAA growth
timeFrame: Up to 10 years of follow-up
measure: AAA rupture
timeFrame: Up to 10 years of follow-up
measure: Death
timeFrame: Up to 10 years of follow-up
measure: Evolution of serum levels of proteases
timeFrame: a maximum of 1 measurement annually up to 10 years of follow-up
measure: Evolution of serum levels of cytokines
timeFrame: a maximum of 1 measurement annually up to 10 years of follow-up
measure: Protease levels in aortic tissue
timeFrame: If open AAA repair is performed and aortic tissue is collected, protease levels will then be measured. This is a one-time measurement.
measure: Cytokine levels in aortic tissue
timeFrame: If open AAA repair is performed and aortic tissue is collected, cytokine levels will then be measured. This is a one-time measurement.
Secondary outcomes:
measure: Type of complications after AAA repair
timeFrame: Will be measured up to 10 years after AAA repair is performed
measure: Incidence of complications after AAA repair
timeFrame: Will be measured up to 10 years after AAA repair is performed
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical Center (LUMC)
state: Zuid-Holland
city: Amsterdam
country: Netherlands
facility: Department of Vascular Surgery, Amsterdam UMC, location AMC
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Ron Balm, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jalalzadeh H, Indrakusuma R, Blankensteijn JD, Wisselink W, Yeung KK, Lindeman JHN, Hamming JF, Koelemay MJW, Legemate DA, Balm R. Design and protocol of a comprehensive multicentre biobank for abdominal aortic aneurysms. BMJ Open. 2019 Aug 1;9(8):e028858. doi: 10.1136/bmjopen-2018-028858.