miRNAsNCT03149406
Study of microRNAs in the Evolution of Carotid Plaque. Physiopathological and Therapeutic Interest
An observational study of miRNAs and Carotid Plaque, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Carotid stenosis of atherosclerotic origin may be responsible for stroke, which is one of the most important causes of morbidity and mortality in the Western world Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- miRNAs, Carotid Plaque
- What is being tested?
- Comparing the expression of miRNAs
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 26 Dec 2012to 26 Dec 2015
- Phase
- Observational
- 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
Study population: Symptomatic patients in the service, and asymptomatic in consultation with carotid atheroma plaque
Who may be able to join
- Any adult with a carotid thrombo endarterectomy,
- affiliated to a social security scheme,
- informed of the study and not opposed to it.
Who cannot join
- Any person benefiting from an iterative carotid surgery,
- or refusing to participate in the study,
- or not being able to express its consent.
Trial locations and contacts
1 site in 1 country.
About this study
Carotid stenosis of atherosclerotic origin may be responsible for stroke, which is one of the most important causes of morbidity and mortality in the Western world
Read the detailed description
Carotid stenosis of atherosclerotic origin may be responsible for stroke, which is one of the most important causes of morbidity and mortality in the Western world. The constitution of the atheroma plaque is linked to the deregulation of several biological phenomena, including angiogenesis, adipogenesis, inflammatory response, lipid metabolism and oxidative stress. In addition to its anatomical and physiological characteristics, the notion of plate stability is of paramount importance for clinical implications. This stability depends largely on the biological composition of the plate. A vulnerable or unstable plaque often has a large lipid body consisting of foam cells (macrophages laden with oxidized LDL) with a thin fibrous screed consisting of smooth muscle cells (CML), collagen fibers and extracellular matrix. This plaque is also made up of numerous inflammatory cells including macrophages, rich vascularization and intraplate hemorrhage. Although the cell composition of the unstable plate is still relatively established, its molecular analysis remains little known.
The benefit of carotid surgery in asymptomatic patients with stenosis greater than 70% is increasingly controversial given the moderate risk of spontaneous stroke under optimal medical treatment. This annual average risk is less than 5%. Thus, the discovery of an original and innovative biomarker, predictive of plate rupture, would define the patients most at risk, who benefit most from this surgery.
- Conditions
- miRNAs, Carotid Plaque
- Being tested
- Comparing the expression of miRNAs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparing the expression of miRNAsOther
by PCR, in symptomatic and asymptomatic carotid plaques.
| Study group | Role | What they receive |
|---|---|---|
| Symptomatic patients | in the department with carotid plaque Comparing the expression of miRNAs Receives: Other: Comparing the expression of miRNAs | |
| Asymptomatic patients | in consultation with carotid plaque Comparing the expression of miRNAs Receives: Other: Comparing the expression of miRNAs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of the miRNAs
by PCR of the composition of the atheroma plaque
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study start26 Dec 2012
- Primary completion26 Dec 2015
- Study completion26 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for miRNAsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thierry REIX, PhD, Principal investigator, CHU AMIENS-PICARDIE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03149406
- Sponsor's protocol ID
- PI2012_843_0019
- Status last verified
- Jun 2026
- First submitted
- 4 May 2017
- Last updated
- 24 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of microRNAs in the Evolution of Carotid Plaque. Physiopathological and Therapeutic Interest
- ClinicalTrials.gov ID
- NCT03149406
- Acronym / sponsor ID
- PI2012_843_0019
- Conditions
- miRNAs, Carotid Plaque
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 26 Dec 2012 (actual)
- Primary completion
- 26 Dec 2015 (actual)
- Study completion
- 26 Dec 2015 (actual)
- First posted
- 11 May 2017 (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.
Carotid stenosis of atherosclerotic origin may be responsible for stroke, which is one of the most important causes of morbidity and mortality in the Western world
Detailed description
Carotid stenosis of atherosclerotic origin may be responsible for stroke, which is one of the most important causes of morbidity and mortality in the Western world. The constitution of the atheroma plaque is linked to the deregulation of several biological phenomena, including angiogenesis, adipogenesis, inflammatory response, lipid metabolism and oxidative stress. In addition to its anatomical and physiological characteristics, the notion of plate stability is of paramount importance for clinical implications. This stability depends largely on the biological composition of the plate. A vulnerable or unstable plaque often has a large lipid body consisting of foam cells (macrophages laden with oxidized LDL) with a thin fibrous screed consisting of smooth muscle cells (CML), collagen fibers and extracellular matrix. This plaque is also made up of numerous inflammatory cells including macrophages, rich vascularization and intraplate hemorrhage. Although the cell composition of the unstable plate is still relatively established, its molecular analysis remains little known.
The benefit of carotid surgery in asymptomatic patients with stenosis greater than 70% is increasingly controversial given the moderate risk of spontaneous stroke under optimal medical treatment. This annual average risk is less than 5%. Thus, the discovery of an original and innovative biomarker, predictive of plate rupture, would define the patients most at risk, who benefit most from this surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Symptomatic patients | – | Other: Comparing the expression of miRNAsin the department with carotid plaque Comparing the expression of miRNAs |
| Asymptomatic patients | – | Other: Comparing the expression of miRNAsin consultation with carotid plaque Comparing the expression of miRNAs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Symptomatic patients in the service, and asymptomatic in consultation with carotid atheroma plaque
Key inclusion criteria (3 listed)
- Any adult with a carotid thrombo endarterectomy,
- affiliated to a social security scheme,
- informed of the study and not opposed to it.
Key exclusion criteria (3 listed)
- Any person benefiting from an iterative carotid surgery,
- or refusing to participate in the study,
- or not being able to express its consent.
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 |
|---|---|---|
| Comparing the expression of miRNAsby PCR, in symptomatic and asymptomatic carotid plaques. | Other | Asymptomatic patients, Symptomatic patients |
Primary outcome
Analysis of the miRNAs
Time frame: 3 years
by PCR of the composition of the atheroma plaque
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 24 Jun 2026.
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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.
Thierry REIX, PhD principal investigator
CHU AMIENS-PICARDIE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of miRNAs and Carotid Plaque, run by Centre Hospitalier Universitaire, Amiens 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 24 Jun 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?
Analysis of the miRNAs (time frame: 3 years). 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 24 Jun 2026.