An observational study in Abdominal Aortic Aneurysm and Abdominal Aortic Aneurysm, Ruptured, sponsored by Ron Balm. Completed at 2 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-22.
Sponsored by Ron Balm · Observational
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
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:
The 'Parelsnoer Institute' will facilitate the biobank Pearl AAA with certain aspects such as, but not limited to the following:
467 studies on the registry are indexed under Aortic Aneurysm, Abdominal; 99 are open to participants now.
This study's enrollment of 790 is above the median of 165 across 217 observational studies indexed under Aortic Aneurysm, Abdominal.
Browse Aortic Aneurysm, Abdominal studies →Ron Balm is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
All adult patients with an abdominal aortic aneurysm who present themselves in the participating hospitals.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
These patients will be included while their AAA is asymptomatic and while they are under surveillance by their vascular surgeon.
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.
These patients are included while they already had had AAA repair (both elective and emergency repair).
AAA growth
Growth of abdominal aortic aneurysm, measured on imaging made for clinical purposes
Time frame: Up to 10 years of follow-up
AAA rupture
Rupture of an abdominal aortic aneurysm
Time frame: Up to 10 years of follow-up
Death
All-cause mortality
Time frame: 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
Time frame: 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
Time frame: a maximum of 1 measurement annually up to 10 years of follow-up
Protease levels in aortic tissue
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.
Cytokine levels in aortic tissue
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.
Type of complications after AAA repair
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
Time frame: Will be measured up to 10 years after AAA repair is performed
Incidence of complications after AAA repair
Number of complications after abdominal aortic aneurysm repair
Time frame: Will be measured up to 10 years after AAA repair is performed
Plan to share: Yes — Researchers can initiate the procedure to request IPD for research that falls within the scientific scope of the biobank Pearl AAA.
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.
Ran from Oct 2017 to primary completion in Aug 2023, 70 months.
Of 67 non-industry observational studies under Aortic Aneurysm, Abdominal, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 83. This study's 70 months is above that.
Counting every sponsor, half of 91 studies reached it within 48 months; a quarter within 24 and three quarters within 83.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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