Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
24 participants
INTERVENTIONAL
2015-02-28
2016-11-22
Brief Summary
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Detailed Description
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For that purpose, several approaches will be used to reach this aim: (1) To evaluate the degree of modification of matrix components at the aneurysmal wall by biological and histological studies (concentrations of PTMDPs (homocitrulline, carboxymethyllysine, pentosidine and MG-H1) and expression of RAGE) ; (2) To determine if there is a link between tissue concentrations of PTMDPs and the severity of the aneurysmal pathology ; (3) To compare concentrations of PTMDPs obtained at the aneurysmal wall with those obtained in skin and serum ; (4) To establish a link between concentrations of PTMDPs (in serum, skin and vascular wall), fragmentation of elastin and different haematological parameters potentially involved in the development of the pathology aneurysmal.
Design of the study: single-center cross-sectional study. Population: 40 patients with aneurysm of the infra-renal abdominal aorta requiring surgical treatment by open surgery. Patients will be divided into 2 groups based on the size of the aneurysm (Group 1: 20 patients with aneurysm diameter of below 75 mm; Group 2: 20 patients with aneurysm diameter above 75 mm; patients a ruptured aneurysm can be included in both groups).
Investigation scheme: after obtaining the inform consent of the patient, several samples or investigations will be done: blood (PTMDPs and hematological paramaters), measurement of skin autofluorescence (AGE-Reader), skin biopsy collection (2 to 3 mm wide and a few centimeters during the laparotomy), a biopsy of both aneurysmal and not aneurysmal aortic wall (from the abdominal aorta fragment usually resected part of the surgery and therefore being surgical waste) and collection of intra-aneurysmal and peri-thrombotic liquid (if available).
Statistical analyses: (1) Description of data using mean and standard deviation for quantitative variables and percentage for qualitative variables. (2) Comparison of PTMDP concentrations between patient groups and between tissue locations (healthy or aortic aneurysms) using the Mann-Whitney test. (3) Search for links between concentrations of tissue PTMDPs, serum, skin autofluorescence, and hematologic markers using the Spearman correlation tests.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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aneurysm diameter of below 75 mm
measurement of skin autofluorescence
skin biopsy collection
aneurysm diameter above 75 mm
measurement of skin autofluorescence
skin biopsy collection
Interventions
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measurement of skin autofluorescence
skin biopsy collection
Eligibility Criteria
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Inclusion Criteria
* Patients older than 18 years.
* Patients who agreed to participate in the study.
Exclusion Criteria
* Patients who have already received surgery for an aneurysm of abdominal aorta.
* Patients who are protected by law.
18 Years
ALL
No
Sponsors
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CHU de Reims
OTHER
Responsible Party
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Locations
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Chu Reims
Reims, , France
Countries
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References
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Doue M, Marques G, Okwieka A, Gorisse L, Pietrement C, Gillery P, Jaisson S. Accumulation of Carbamylation-Derived Products in Aneurysmal Aorta. J Vasc Res. 2024;61(2):51-58. doi: 10.1159/000534613. Epub 2024 Jan 19.
Other Identifiers
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PO14056
Identifier Type: -
Identifier Source: org_study_id
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