Abdominal Aorta AneurysmACTA-miRNANCT03974958
Circulating microRNAs and Degenerative Abdominal Aorta Aneurysm
A study testing Tissue-library in people with Abdominal Aorta Aneurysm, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Abdominal aortic aneurysm (AAA) is an aortic dilatation superior or equal to 30 mm with an estimated prevalence at 8% in men over 65 year-old. It evolves with no clinical signal until the rupture of the aortic wall with dramatic outcomes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Abdominal Aorta Aneurysm
- What is being tested?
- Tissue-library
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteFrance
- Study dates
- 2 Oct 2018to 21 Mar 2022
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Case AAA T3 : Patients included in the ACTA study. They benefited from aortic imaging assessment at times T1 and T2 and were not operated on AAA.
- AOMI Case Control : Patients referred for hospitalization or referred to vascular surgery for management of chronic peripheral claudication on AOMI not associated with aneuric aneurysm evolutionary or previously operated. They must benefit from a CT angiography of the aorta and lower extremity arteries as well as a cardiac ultrasound scan.
Who cannot join
- minor patients;
- pregnant women;
- patients with cancer at the time of inclusion;
- contraindication to iodinated contrast medium: allergy to iodine, severe renal insufficiency (≤40 ml / min);
- patients presenting one of the following pathologies associated with a disruption of the activation of coagulation and / or inflammation (less than 6 weeks old):
- Arterial thrombotic disease: acute coronary syndrome, TIA/CVD, peripheral artery acute ischemia and/or anti-vitamin K (AVK) treatment;
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- venous thrombotic pathology: peripheral venous thrombosis of less than 3 months and/or under AVK treatment, pulmonary embolism less than 6 months old and/or under AVK treatment;
- surgery;
- revascularization with angioplasty;
- critical ischemia patente;
- permanent atrial fibrillation due to associated microparticle elevation, and AVK treatment;
- major haemorrhage;
- acute infection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Circulating microRNAs and Degenerative Abdominal Aorta Aneurysm: Diagnostic Specificity and Prognostic Value in Clinical Practice
Abdominal aortic aneurysm (AAA) is an aortic dilatation superior or equal to 30 mm with an estimated prevalence at 8% in men over 65 year-old. It evolves with no clinical signal until the rupture of the aortic wall with dramatic outcomes. The pathophysiological mechanisms include extracellular matrix remodeling, smooth muscle cells apoptosis, aggregation and activation of inflammatory cells in the aortic wall and heredity. The initiating and regulatory processes are complex and not fully elucidated. They encompass local aortic environment (flux, thrombus, wall shear stress, pressure and adipose tissue) and patient-dependent genetic (de)regulation.
This project follows the previous prospective ACTA study that aimed at identifying clinical criteria, circulating biomarkers or imaging data for thoracic aneurysm prognosis in an AAA population. The preliminary results showed that 1) a low wall shear stress index and the luminal volume are more predictive values for a rapid AAA growth and an intraluminal thrombus than the maximal aortic diameter 2) three thoracic aortic phenotypes (normal, dilated, aneurysmal) stratify the disease extent 3) the age and the female gender are associated to an extended disease. During this study we created a biobank in which blood samples of AAA patients were collected at the time of their inclusion (T1). This new ACTA-miRNA study aims at correlating circulating biomarkers to the anatomical and biomechanical markers previously highlighted for a rapid aneurysmal growth. Circulating miRNA are involved in parietal remodeling and constitute promising targets for estimating patients-specific aortic risk.
Read more
From the literature, we thus selected 18 miRNA described to be involved in AAA biology: inflammation, remodeling, cellular homeostasis and wall shear stress. As control, we select non-AAA patients presenting with peripheral arterial obstructive disease (PAOD) matched in age, BMI, tobacco consumption, diabetes, cholesterol level and blood pressure with AAA patients enrolled in the ACTA study. During their follow-up, these ACTA patients are solicited to continue the program research and can participate to the ACTA-miRNA study. A third time analysis is performed for them (T3): we collect imaging data of total aorta required by their standard follow-up, as well as a blood sample. Differential analysis of the miRNA panel will be conducted between 1) AAA patients (T1) vs PAOD patients 2) fast-growing AAA vs slow-growing AAA 3) AAA \& AAT patient group vs AAA alone and/or AAA \& dilatation of thoracic aorta. 110 patients from the ACTA study are eligible to be included into the ACTA mi-RNA study. Inclusion of PAOD controls will be conducted until the number of 165 cases is reached (1:1.5 ratio).
Our primary objective is to validate a circulating-miRNA signature specific for abdominal aortic aneurysm.
- Conditions
- Abdominal Aorta Aneurysm
- Being tested
- Tissue-library
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue-libraryGenetic
circulating biomarkers (miRNA panel) analysis of blood samples
| Study group | Role | What they receive |
|---|---|---|
| AAA patients | Experimental | Patients with abdominal aortic aneurysm (AAA) Receives: Genetic: Tissue-library |
| PAOD patients | Experimental | patients with peripheral arterial obstructive disease (PAOD) Receives: Genetic: Tissue-library |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of AAA miRNAs vs AOMI miRNAs
Analyze the diagnostic value of the 18 selected microRNAs circulating profile in degenerative aneurysmal aortic remodeling (patients with an abdominal aortic aneurysm (AAA)) in comparison with the circulating profile of the same 18 microRNAs panel in the atherosclerosis remodeling (patients with peripheral arterial occlusive disease (AOMI) without AAA)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start2 Oct 2018
- Primary completion21 Mar 2022
- Study completion21 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aorta AneurysmStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emilie Garrido Pradalié, Study director, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03974958
- Sponsor's protocol ID
- 2018-12
- Acronym
- ACTA-miRNA
- Status last verified
- Jul 2023
- First submitted
- 3 Jun 2019
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating microRNAs and Degenerative Abdominal Aorta Aneurysm: Diagnostic Specificity and Prognostic Value in Clinical Practice
- ClinicalTrials.gov ID
- NCT03974958
- Acronym / sponsor ID
- ACTA-miRNA / 2018-12
- Conditions
- Abdominal Aorta Aneurysm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 2 Oct 2018 (actual)
- Primary completion
- 21 Mar 2022 (actual)
- Study completion
- 21 Mar 2022 (actual)
- First posted
- 5 Jun 2019 (actual)
- 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.
Abdominal aortic aneurysm (AAA) is an aortic dilatation superior or equal to 30 mm with an estimated prevalence at 8% in men over 65 year-old. It evolves with no clinical signal until the rupture of the aortic wall with dramatic outcomes. The pathophysiological mechanisms include extracellular matrix remodeling, smooth muscle cells apoptosis, aggregation and activation of inflammatory cells in the aortic wall and heredity. The initiating and regulatory processes are complex and not fully elucidated. They encompass local aortic environment (flux, thrombus, wall shear stress, pressure and adipose tissue) and patient-dependent genetic (de)regulation.
This project follows the previous prospective ACTA study that aimed at identifying clinical criteria, circulating biomarkers or imaging data for thoracic aneurysm prognosis in an AAA population. The preliminary results showed that 1) a low wall shear stress index and the luminal volume are more predictive values for a rapid AAA growth and an intraluminal thrombus than the maximal aortic diameter 2) three thoracic aortic phenotypes (normal, dilated, aneurysmal) stratify the disease extent 3) the age and the female gender are associated to an extended disease. During this study we created a biobank in which blood samples of AAA patients were collected at the time of their inclusion (T1). This new ACTA-miRNA study aims at correlating circulating biomarkers to the anatomical and biomechanical markers previously highlighted for a rapid aneurysmal growth. Circulating miRNA are involved in parietal remodeling and constitute promising targets for estimating patients-specific aortic risk.
From the literature, we thus selected 18 miRNA described to be involved in AAA biology: inflammation, remodeling, cellular homeostasis and wall shear stress. As control, we select non-AAA patients presenting with peripheral arterial obstructive disease (PAOD) matched in age, BMI, tobacco consumption, diabetes, cholesterol level and blood pressure with AAA patients enrolled in the ACTA study. During their follow-up, these ACTA patients are solicited to continue the program research and can participate to the ACTA-miRNA study. A third time analysis is performed for them (T3): we collect imaging data of total aorta required by their standard follow-up, as well as a blood sample. Differential analysis of the miRNA panel will be conducted between 1) AAA patients (T1) vs PAOD patients 2) fast-growing AAA vs slow-growing AAA 3) AAA \& AAT patient group vs AAA alone and/or AAA \& dilatation of thoracic aorta. 110 patients from the ACTA study are eligible to be included into the ACTA mi-RNA study. Inclusion of PAOD controls will be conducted until the number of 165 cases is reached (1:1.5 ratio).
Our primary objective is to validate a circulating-miRNA signature specific for abdominal aortic aneurysm.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AAA patients | Experimental | Genetic: Tissue-libraryPatients with abdominal aortic aneurysm (AAA) |
| PAOD patients | Experimental | Genetic: Tissue-librarypatients with peripheral arterial obstructive disease (PAOD) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Case AAA T3 : Patients included in the ACTA study. They benefited from aortic imaging assessment at times T1 and T2 and were not operated on AAA.
- AOMI Case Control : Patients referred for hospitalization or referred to vascular surgery for management of chronic peripheral claudication on AOMI not associated with aneuric aneurysm evolutionary or previously operated. They must benefit from a CT angiography of the aorta and lower extremity arteries as well as a cardiac ultrasound scan.
Key exclusion criteria (13 listed)
- minor patients;
- pregnant women;
- patients with cancer at the time of inclusion;
- contraindication to iodinated contrast medium: allergy to iodine, severe renal insufficiency (≤40 ml / min);
- patients presenting one of the following pathologies associated with a disruption of the activation of coagulation and / or inflammation (less than 6 weeks old):
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 |
|---|---|---|
| Tissue-librarycirculating biomarkers (miRNA panel) analysis of blood samples | Genetic | AAA patients, PAOD patients |
Primary outcome
Comparison of AAA miRNAs vs AOMI miRNAs
Time frame: 24 months
Analyze the diagnostic value of the 18 selected microRNAs circulating profile in degenerative aneurysmal aortic remodeling (patients with an abdominal aortic aneurysm (AAA)) in comparison with the circulating profile of the same 18 microRNAs panel in the atherosclerosis remodeling (patients with peripheral arterial occlusive disease (AOMI) without AAA)
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 27 Jul 2023.
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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.
Emilie Garrido Pradalié study director
Assistance Publique Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tissue-library in people with Abdominal Aorta Aneurysm, run by Assistance Publique Hopitaux De Marseille 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 2 inclusion and 13 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 27 Jul 2023. 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?
Comparison of AAA miRNAs vs AOMI miRNAs (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jul 2023; AzTrials last refreshed its copy on 31 Oct 2026.