- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02784769
Matrix Aging and Aneurysm (VIMANE)
Role of Molecular Aging of Matrix Proteins of the Vessel Wall in the Aneurysm Pathology
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The investigators hypothesized that the molecular aging of matrix proteins may participate in the formation of aortic aneurysm. Indeed, it is well known that the aneurysm wall is subjected to important structural changes including variations in extracellular matrix composition. However, few studies have looked for a link between the molecular aging of matrix proteins and the formation of aneurysm. So, the aim of this study is to understand the role of protein molecular aging in this context.
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Reims, France, 51092
- CHU Reims
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with aneurysm of the infrarenal abdominal aorta requiring surgical care by open surgery.
- Patients older than 18 years.
- Patients who agreed to participate in the study.
Exclusion Criteria:
- Patients with aneurysm of the abdominal infrarenal aorta due to trauma or infection.
- Patients who have already received surgery for an aneurysm of abdominal aorta.
- Patients who are protected by law.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: aneurysm diameter of below 75 mm
|
|
Experimental: aneurysm diameter above 75 mm
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
blood collection
Time Frame: at the same time of surgery
|
at the same time of surgery
|
measurement of skin autofluorescence with AGE-reader (Diagnoptics®)
Time Frame: at the same time of surgery
|
at the same time of surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PO14056
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Aortic Aneurysm
-
University of BolognaCompletedThoracoabdominal Aortic Aneurysm | Ruptured Thoracic Aneurysm | Ruptured Aortic Aneurysm | Thoracoabdominal Aortic Aneurysm, RupturedItaly
-
Gustavo OderichWilliam Cook AustraliaRecruitingThoracoabdominal Aortic Aneurysm | Aortic Arch Aneurysm | Complex Abdominal Aortic Aneurysm | Aortic Arch DissectionUnited States
-
Baptist Health South FloridaWilliam Cook AustraliaRecruitingThoracoabdominal Aortic Aneurysm | Aortic Arch AneurysmUnited States
-
University of California, San DiegoRecruitingJuxtarenal Aortic Aneurysm | Thoracoabdominal Aortic Aneurysm | Pararenal Aortic Aneurysm | Complex Abdominal Aortic AneurysmUnited States
-
University of South FloridaMedtronic; Sanford HealthActive, not recruiting
-
University of North Carolina, Chapel HillCook Group Incorporated; UNC HospitalsEnrolling by invitationAortic Aneurysm, Abdominal | Aortic Arch Aneurysm | Ascending Aorta AneurysmUnited States
-
Karolinska University HospitalEnrolling by invitationAneurysm | Aortic Aneurysm | Abdominal Aortic Aneurysm, Ruptured | Aneurysm Abdominal | Abdominal Aortic Aneurysm Without RuptureSweden
-
Rede Optimus Hospitalar SAShockwave Medical, Inc.Not yet recruitingThoracoabdominal Aortic Aneurysm, Without Mention of Rupture | Abdominal Aortic Aneurysm Without Rupture | Thoracic Aortic Aneurysm Without Rupture
-
CEVARIIUniversity of Colorado, Denver; University of Copenhagen; University of Iowa; University... and other collaboratorsEnrolling by invitationComplex EVAR in Inflammatory and Infective Abdominal and Thoracoabdominal Aortic Aneurysms (CEVARII)Abdominal Aortic Aneurysm | Thoracoabdominal Aortic Aneurysm | Aneurysm, Infected | Inflammatory Abdominal Aortic Aneurysm | Aneurysm, MycoticUnited States
-
W.L.Gore & AssociatesRecruitingThoracic Aortic Aneurysm | Abdominal Aortic AneurysmSpain, Denmark, Italy, Norway, Netherlands, Sweden
Clinical Trials on measurement of skin autofluorescence
-
Novosanis NVCompleted
-
Nantes University HospitalCompleted
-
Massachusetts General HospitalProcter and GambleTerminatedHealthy | Sun ExposureUnited States
-
Assistance Publique - Hôpitaux de ParisSociété Française de lutte contre les cancers et leucémies de l'enfant et...CompletedChemotherapy-induced Peripheral NeuropathyFrance
-
Mahidol UniversityCompletedInsect Sting Allergy
-
Rutgers, The State University of New JerseyTerminated
-
University of ViennaMedical University of ViennaCompletedSkin Physiology | Dermal Administration | EmulsionsAustria
-
Zurich University of Applied SciencesUnknown
-
University Hospital, MontpellierActive, not recruiting