CompletedNot Applicable

Predicting Aneurysm Growth and Rupture With Longitudinal Biomarkers

Netherlands790 participantsStarted 2017-10-04

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

AAA growth

Timeframe: Up to 10 years of follow-up

AAA rupture

Timeframe: Up to 10 years of follow-up

Death

Timeframe: Up to 10 years of follow-up

Evolution of serum levels of proteases

Timeframe: a maximum of 1 measurement annually up to 10 years of follow-up

Evolution of serum levels of cytokines

Timeframe: a maximum of 1 measurement annually up to 10 years of follow-up

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.

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.

Trial details

NCT IDNCT03320408

SponsorRon Balm

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-08-04

View on ClinicalTrials.gov More Abdominal Aortic Aneurysm trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

AAA growth

Timeframe: Up to 10 years of follow-up

AAA rupture

Timeframe: Up to 10 years of follow-up

Death

Timeframe: Up to 10 years of follow-up

Evolution of serum levels of proteases

Timeframe: a maximum of 1 measurement annually up to 10 years of follow-up

Evolution of serum levels of cytokines

Timeframe: a maximum of 1 measurement annually up to 10 years of follow-up

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.

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.