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NCT03146221 Clinical Trial

Search for Restenosis Markers in Lower Limb Arteritis

Restenosis Clinical Trial

— FEMIA  

Official title:
Search for Restenosis Markers in Lower Limb Arteritis

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT03146221
Other study ID # PI2016_843_0004
Secondary ID
Status Withdrawn
Phase N/A
First received May 2, 2017
Last updated July 19, 2017
Start date June 20, 2017
Est. completion date June 20, 2020

Study information
Verified date July 2017
Source Centre Hospitalier Universitaire, Amiens
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The initial hypothesis of this work is that the genesis and the evolution of the atheromatous plaque are partly controlled at the molecular level and in particular by the microRNAs through their role as regulator of the genes.

The study of the tissue and serum profile over time of specific microRNAs involved in the regulation of atheromatous plaque correlated with clinical data and restenosis imaging will allow to define biological markers of restenosis in the patient with an arteritis of the lower limbs .

This study is a pioneer in the field and it would be imprudent to conclude that a biomarker would be used clinically at the end of this work alone. Nevertheless this study will make a major advance in this topic, in vivo intervention studies with inhibition or over-expression of microRNA will obviously be necessary to confirm the use of these as biomarkers of arteritis of the lower limbs.

Regular assay of reliable biomarkers in arterial patients will ultimately suggest early management to best adapt surgical and medical treatment.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date June 20, 2020
Est. primary completion date June 20, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Any person to be surgically treated for arteritis on the femoropoplitetic stage,

- affiliated to a social security scheme,

- informed of the study and not opposed to it.

Exclusion Criteria:

- Any person taken in charge for an arteritis on the femoro-popliteal floor refusing to participate in the study,

- or not being able to express its consent.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• To look for serum microRNA profiles associated with restenosis
To look for serum microRNA profiles associated with restenosis

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 Study of the tissue and serum profile of microRNAs by quantification by real-time PCR 3 years
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