Predicting Aneurysm Growth and Rupture With Longitudinal Biomarkers
Λέξεις-κλειδιά
Αφηρημένη
Περιγραφή
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
Ημερομηνίες
| Τελευταία επαλήθευση: | 06/30/2020 |
| Πρώτα υποβλήθηκε: | 10/11/2017 |
| Υποβλήθηκε εκτιμώμενη εγγραφή: | 10/22/2017 |
| Δημοσιεύτηκε για πρώτη φορά: | 10/24/2017 |
| Υποβλήθηκε τελευταία ενημέρωση: | 07/08/2020 |
| Δημοσιεύτηκε η τελευταία ενημέρωση: | 07/09/2020 |
| Ημερομηνία έναρξης της πραγματικής μελέτης: | 10/03/2017 |
| Εκτιμώμενη κύρια ημερομηνία ολοκλήρωσης: | 10/03/2032 |
| Εκτιμώμενη ημερομηνία ολοκλήρωσης μελέτης: | 10/03/2032 |
Κατάσταση ή ασθένεια
Φάση
Ομάδες βραχιόνων
| Μπράτσο | Παρέμβαση / θεραπεία |
|---|---|
| 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). |
Κριτήρια καταλληλότητας
| Επιλέξιμες ηλικίες για μελέτη | 18 Years Προς την 18 Years |
| Φύλα επιλέξιμα για μελέτη | All |
| Μέθοδος δειγματοληψίας | Probability Sample |
| Δέχεται υγιείς εθελοντές | Ναί |
| Κριτήρια | 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. |
Αποτέλεσμα
Πρωτεύοντα αποτελέσματα
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.]
Δευτερεύοντα αποτελέσματα
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]
