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

NCT ID: NCT03149406

Last Updated: 2018-08-03

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 245 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-12-26
• Study Completion Date: 2020-12-26

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.

Conditions

miRNAs; Carotid Plaque

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Symptomatic patients

in the department with carotid plaque Comparing the expression of miRNAs

Comparing the expression of miRNAs

Intervention Type: OTHER

by PCR, in symptomatic and asymptomatic carotid plaques.

Asymptomatic patients

in consultation with carotid plaque Comparing the expression of miRNAs

Comparing the expression of miRNAs

Intervention Type: OTHER

by PCR, in symptomatic and asymptomatic carotid plaques.

Interventions

Comparing the expression of miRNAs

by PCR, in symptomatic and asymptomatic carotid plaques.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thierry REIX, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU AMIENS-PICARDIE

Locations

CHU Amiens Picardie

Amiens, Picardie, France

Site Status: RECRUITING

Countries

France

Central Contacts

Thierry REIX, PhD

Role: CONTACT

reix.thierry@chu-amiens.fr

+33322455929

Facility Contacts

Thierry REIX, PhD

Role: primary

reix.thierry@chu-amiens.fr

+33322455929

Other Identifiers

PI2012_843_0019

Identifier Type: -

Identifier Source: org_study_id