Search for Restenosis Markers in Lower Limb Arteritis (FEMIA)

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.

Study Overview

• Status: Withdrawn
• Conditions: Restenosis; Lower Limb Arteritis
• Intervention / Treatment: Other: To look for serum microRNA profiles associated with restenosis

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Picardie
    • Amiens, Picardie, France, 80054
      • CHU Amiens Picardie

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Person to be surgically treated for arteritis	Other: To look for serum microRNA profiles associated with restenosis; To look for serum microRNA profiles associated with restenosis

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens

Study record dates

Study Major Dates

• Study Start (Anticipated): June 20, 2017
• Primary Completion (Anticipated): June 20, 2020
• Study Completion (Anticipated): June 20, 2020

Study Registration Dates

• First Submitted: May 2, 2017
• First Submitted That Met QC Criteria: May 4, 2017
• First Posted (Actual): May 9, 2017

Study Record Updates

• Last Update Posted (Actual): July 21, 2017
• Last Update Submitted That Met QC Criteria: July 19, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Vasculitis; Arteritis
• Other Study ID Numbers: PI2016_843_0004

Drug and device information, study documents

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