Study of microRNAs in the Evolution of Carotid Plaque. Physiopathological and Therapeutic Interest

• Conditions: miRNAs; Carotid Plaque
• Interventions: Other: Comparing the expression of miRNAs

• Registration Number: NCT03149406
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief 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

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 Timeline

• Study Start: 2012-12-26
• Study First Submitted: 2017-05-04
• Study First Submitted QC: 2017-05-09
• Study First Posted: 2017-05-11
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-02
• Last Update Posted: 2018-08-03
• Primary Completion: 2020-12-26
• Study Completion: 2020-12-26

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 245

Inclusion Criteria

• Any adult with a carotid thrombo endarterectomy,
• affiliated to a social security scheme,
• informed of the study and not opposed to it.

Exclusion Criteria

• Any person benefiting from an iterative carotid surgery,
• or refusing to participate in the study,
• or not being able to express its consent.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Asymptomatic patients	Comparing the expression of miRNAs	in consultation with carotid plaque Comparing the expression of miRNAs
Symptomatic patients	Comparing the expression of miRNAs	in the department with carotid plaque Comparing the expression of miRNAs

Primary Outcome Measures

Name	Time	Method
Analysis of the miRNAs	3 years	by PCR of the composition of the atheroma plaque

Trial Locations

Locations (1)

CHU Amiens Picardie; 🇫🇷 Amiens, Picardie, France