Predicting Aneurysm Growth and Rupture With Longitudinal Biomarkers
关键词
抽象
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
日期
| 最后验证: | 06/30/2020 |
| 首次提交: | 10/11/2017 |
| 提交的预估入学人数: | 10/22/2017 |
| 首次发布: | 10/24/2017 |
| 上次提交的更新: | 07/08/2020 |
| 最近更新发布: | 07/09/2020 |
| 实际学习开始日期: | 10/03/2017 |
| 预计主要完成日期: | 10/03/2032 |
| 预计完成日期: | 10/03/2032 |
状况或疾病
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| 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). |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 取样方式 | Probability Sample |
| 接受健康志愿者 | 是 |
| 标准 | 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. |
结果
主要结果指标
1. AAA growth [Up to 10 years of follow-up]
2. AAA rupture [Up to 10 years of follow-up]
3. Death [Up to 10 years of follow-up]
4. Evolution of serum levels of proteases [a maximum of 1 measurement annually up to 10 years of follow-up]
5. Evolution of serum levels of cytokines [a maximum of 1 measurement annually up to 10 years of follow-up]
6. 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.]
7. 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.]
次要成果指标
1. Type of complications after AAA repair [Will be measured up to 10 years after AAA repair is performed]
2. Incidence of complications after AAA repair [Will be measured up to 10 years after AAA repair is performed]
