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

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

Study Overview

• Status: Unknown
• Conditions: miRNAs; Carotid Plaque
• Intervention / Treatment: Other: Comparing the expression of miRNAs

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 Type: Observational
• Enrollment (Anticipated): 245

Contacts and Locations

Study Locations

• France
  • Picardie
    • Amiens, Picardie, France, 80054
      • Recruiting
      • CHU Amiens Picardie
      • Contact: Thierry REIX, PhD; Phone Number: +33322455929; Email: reix.thierry@chu-amiens.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Symptomatic patients in the service, and asymptomatic in consultation with carotid atheroma plaque

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Symptomatic patients; in the department with carotid plaque Comparing the expression of miRNAs	Other: Comparing the expression of miRNAs; by PCR, in symptomatic and asymptomatic carotid plaques.
Asymptomatic patients; in consultation with carotid plaque Comparing the expression of miRNAs	Other: Comparing the expression of miRNAs; by PCR, in symptomatic and asymptomatic carotid plaques.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analysis of the miRNAs	by PCR of the composition of the atheroma plaque	3 years

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Investigators: Principal Investigator: Thierry REIX, PhD, CHU Amiens-Picardie

Study record dates

Study Major Dates

• Study Start (Actual): December 26, 2012
• Primary Completion (Anticipated): December 26, 2020
• Study Completion (Anticipated): December 26, 2020

Study Registration Dates

• First Submitted: May 4, 2017
• First Submitted That Met QC Criteria: May 9, 2017
• First Posted (Actual): May 11, 2017

Study Record Updates

• Last Update Posted (Actual): August 3, 2018
• Last Update Submitted That Met QC Criteria: August 2, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: PI2012_843_0019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No