Abdominal Aortic Aneurysm Clinical Trial
— PARISOfficial title:
Predicting Aneurysm Growth and Rupture With Longitudinal Biomarkers (PARIS Study) & Biobank Pearl AAA
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
Status | Completed |
Enrollment | 790 |
Est. completion date | August 4, 2023 |
Est. primary completion date | August 4, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Netherlands | Department of Vascular Surgery, Amsterdam UMC, location AMC | Amsterdam | |
Netherlands | Leiden University Medical Center (LUMC) | Leiden | Zuid-Holland |
Lead Sponsor | Collaborator |
---|---|
Ron Balm |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | AAA growth | Growth of abdominal aortic aneurysm, measured on imaging made for clinical purposes | Up to 10 years of follow-up | |
Primary | AAA rupture | Rupture of an abdominal aortic aneurysm | Up to 10 years of follow-up | |
Primary | Death | All-cause mortality | Up to 10 years of follow-up | |
Primary | 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 | |
Primary | 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 | |
Primary | 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. | |
Primary | 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 | 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 | Will be measured up to 10 years after AAA repair is performed | |
Secondary | Incidence of complications after AAA repair | Number of complications after abdominal aortic aneurysm repair | Will be measured up to 10 years after AAA repair is performed |
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