Aortic AneurysmVIMANENCT02784769
Matrix Aging and Aneurysm
A study testing measurement of skin autofluorescence and skin biopsy collection in people with Aortic Aneurysm, run by CHU de Reims at 1 site in France.
Trial summary
During their biological life, proteins undergo molecular aging due to many non-enzymatic post-translational modifications that alter their structural and functional properties. These reactions concern all proteins but especially tissue proteins (whose half-life in the organism can be several decades) and lead to the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Aneurysm
- What is being tested?
- measurement of skin autofluorescence and skin biopsy collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2015to 22 Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Molecular Aging of Matrix Proteins of the Vessel Wall in the Aneurysm Pathology
During their biological life, proteins undergo molecular aging due to many non-enzymatic post-translational modifications that alter their structural and functional properties. These reactions concern all proteins but especially tissue proteins (whose half-life in the organism can be several decades) and lead to the formation of complex products called PTMDPs ("post-translational modification derived products"). Molecular aging is responsible for the alteration of protein properties which may cause changes in mechanical properties of tissues during aging and pathologies. However, the involvement of these processes in vivo remains unclear, particularly in the aneurysmal pathology. So, the aim of this study is to determine whether the molecular aging of matrix proteins within the vessel wall may participate in the development of aortic aneurysm.
Read the 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.
- Conditions
- Aortic Aneurysm
- Being tested
- measurement of skin autofluorescence, skin biopsy collection
- Medical subject headings
- Aortic Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measurement of skin autofluorescenceOther
skin biopsy collectionOther
| Study group | Role | What they receive |
|---|---|---|
| aneurysm diameter of below 75 mm | Experimental | Not described Receives: Other: measurement of skin autofluorescence; Other: skin biopsy collection |
| aneurysm diameter above 75 mm | Experimental | Not described Receives: Other: measurement of skin autofluorescence; Other: skin biopsy collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood collection
Measured: at the same time of surgery
measurement of skin autofluorescence with AGE-reader (Diagnoptics®)
Measured: at the same time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2016 (estimated)
- Study startFeb 2015
- Primary completion22 Nov 2016
- Study completion22 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02784769
- Sponsor's protocol ID
- PO14056
- Acronym
- VIMANE
- Status last verified
- Apr 2018
- First submitted
- 20 May 2016
- Last updated
- 21 Jan 2026
- Results posted
- No
Publications
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.
PubMed 38246153
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Molecular Aging of Matrix Proteins of the Vessel Wall in the Aneurysm Pathology
- ClinicalTrials.gov ID
- NCT02784769
- Acronym / sponsor ID
- VIMANE / PO14056
- Conditions
- Aortic Aneurysm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- 22 Nov 2016 (actual)
- Study completion
- 22 Nov 2016 (actual)
- First posted
- 27 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
During their biological life, proteins undergo molecular aging due to many non-enzymatic post-translational modifications that alter their structural and functional properties. These reactions concern all proteins but especially tissue proteins (whose half-life in the organism can be several decades) and lead to the formation of complex products called PTMDPs ("post-translational modification derived products"). Molecular aging is responsible for the alteration of protein properties which may cause changes in mechanical properties of tissues during aging and pathologies. However, the involvement of these processes in vivo remains unclear, particularly in the aneurysmal pathology. So, the aim of this study is to determine whether the molecular aging of matrix proteins within the vessel wall may participate in the development of aortic aneurysm.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aneurysm diameter of below 75 mm | Experimental | Other: measurement of skin autofluorescence, Other: skin biopsy collection |
| aneurysm diameter above 75 mm | Experimental | Other: measurement of skin autofluorescence, Other: skin biopsy collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| measurement of skin autofluorescence | Other | aneurysm diameter above 75 mm, aneurysm diameter of below 75 mm |
| skin biopsy collection | Other | aneurysm diameter above 75 mm, aneurysm diameter of below 75 mm |
Primary outcome
blood collection
Time frame: at the same time of surgery
measurement of skin autofluorescence with AGE-reader (Diagnoptics®)
Time frame: at the same time of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Background: PubMed 38246153Doue 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing measurement of skin autofluorescence and skin biopsy collection in people with Aortic Aneurysm, run by CHU de Reims at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood collection (time frame: at the same time of surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02784769, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.