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

Carotid Plaque Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03149406
• Other study ID #: PI2012_843_0019
• Status: Recruiting
• Start date: December 26, 2012
• Est. completion date: December 26, 2020

Study information

• Verified date: August 2018
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Thierry REIX, PhD
• Phone: +33322455929
• Email: reix.thierry[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 245
• Est. completion date: December 26, 2020
• Est. primary completion date: December 26, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carotid Plaque
• miRNAs

Intervention

Other:
• Comparing the expression of miRNAs
by PCR, in symptomatic and asymptomatic carotid plaques.

Locations

Country	Name	City	State
France	CHU Amiens Picardie	Amiens	Picardie

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analysis of the miRNAs	by PCR of the composition of the atheroma plaque	3 years