Predicting Aneurysm Growth and Rupture With Longitudinal Biomarkers (PARIS Study) & Biobank Pearl AAA
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 790
- 试验地点
- 2
- 主要终点
- Evolution of serum levels of proteases
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Evolution of serum levels of proteases
时间窗: a maximum of 1 measurement annually up to 10 years of follow-up
Repeated measurements analysis of serum levels of proteases in cohort of asymptomatic AAAs
Protease levels in aortic tissue
时间窗: If open AAA repair is performed and aortic tissue is collected, protease levels will then be measured. This is a one-time measurement.
Protease levels in aortic tissue
Cytokine levels in aortic tissue
时间窗: If open AAA repair is performed and aortic tissue is collected, cytokine levels will then be measured. This is a one-time measurement.
Cytokine levels in aortic tissue
Evolution of serum levels of cytokines
时间窗: a maximum of 1 measurement annually up to 10 years of follow-up
Repeated measurements analysis of serum levels of cytokines in cohort of asymptomatic AAAs
AAA rupture
时间窗: Up to 10 years of follow-up
Rupture of an abdominal aortic aneurysm
AAA growth
时间窗: Up to 10 years of follow-up
Growth of abdominal aortic aneurysm, measured on imaging made for clinical purposes
Death
时间窗: Up to 10 years of follow-up
All-cause mortality
次要结局
- 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)
研究者
Ron Balm
Principal Investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)