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Search for Restenosis Markers in Lower Limb Arteritis (FEMIA)

Primary Purpose

Restenosis, Lower Limb Arteritis

Status
Withdrawn
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
To look for serum microRNA profiles associated with restenosis
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Restenosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHU Amiens Picardie

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Person to be surgically treated for arteritis

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 2, 2017
Last Updated
July 19, 2017
Sponsor
Centre Hospitalier Universitaire, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT03146221
Brief Title
Search for Restenosis Markers in Lower Limb Arteritis
Acronym
FEMIA
Official Title
Search for Restenosis Markers in Lower Limb Arteritis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Withdrawn
Why Stopped
investigator wish
Study Start Date
June 20, 2017 (Anticipated)
Primary Completion Date
June 20, 2020 (Anticipated)
Study Completion Date
June 20, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Restenosis, Lower Limb Arteritis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Person to be surgically treated for arteritis
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
To look for serum microRNA profiles associated with restenosis
Intervention Description
To look for serum microRNA profiles associated with restenosis
Primary Outcome Measure Information:
Title
Study of the tissue and serum profile of microRNAs by quantification by real-time PCR
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
CHU Amiens Picardie
City
Amiens
State/Province
Picardie
ZIP/Postal Code
80054
Country
France

12. IPD Sharing Statement

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Search for Restenosis Markers in Lower Limb Arteritis

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