Predicting Aneurysm Growth and Rupture With Longitudinal Biomarkers

NCT03320408 | Completed

• 2 other identifiers: NL59991.018.17Biobank Pearl AAA
• Study Type: observational
• Target: 790
• Locations: 1 country
• Sites: 2

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

Conditions

Abdominal Aortic Aneurysm; Abdominal Aortic Aneurysm, Ruptured

Keywords

biobank; pathogenesis; Aortic Aneurysm

Outcome Measures

Primary Outcomes (7)

• AAA growth

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

  Up to 10 years of follow-up

• AAA rupture

  Rupture of an abdominal aortic aneurysm

  Up to 10 years of follow-up

• Death

  All-cause mortality

  Up to 10 years of follow-up

• Evolution of serum levels of proteases

  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

  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

  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

  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 Outcomes (2)

• Type of complications after AAA repair

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

• Incidence of complications after AAA repair

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

Study Arms (3)

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ron Balm: lead

Study Sites (2)

Leiden University Medical Center (LUMC)

Leiden, South Holland, 2333ZA, Netherlands

Location

Department of Vascular Surgery, Amsterdam UMC, location AMC

Amsterdam, 1105 AZ, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 31375618 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Three types of biospecimens will be collected, depending on the clincial stage of the abdominal aortic aneurysm. Blood: EDTA plasma; Serum; Citrate plasma; EDTA for DNA; PAXgene for RNA. Urine. Aneurysm tissue

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Rupture; Aortic Aneurysm

Condition Hierarchy (Ancestors)

Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Wounds and Injuries

Study Officials

• Ron Balm, MD PhD

  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 12, 2017
• First Posted: October 25, 2017
• Study Start: October 4, 2017
• Primary Completion: August 4, 2023
• Study Completion: August 4, 2023
• Last Updated: August 22, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: Depending on the specific study protocols that are submitted to the biobank Pearl AAA
• Access Criteria: Procedural criteria can be attained by contacting the researchers.

Locations

NL (2)