Search for Restenosis Markers in Lower Limb Arteritis

NCT03146221 | Withdrawn

• 1 other identifier: PI2016_843_0004
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Restenosis; Lower Limb Arteritis

Outcome Measures

Primary Outcomes (1)

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

  3 years

Study Arms (1)

Person to be surgically treated for arteritis

OTHER

Other: To look for serum microRNA profiles associated with restenosis

Interventions

To look for serum microRNA profiles associated with restenosis OTHER

To look for serum microRNA profiles associated with restenosis

Person to be surgically treated for arteritis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens Picardie

Amiens, Picardie, 80054, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2017
• First Posted: May 9, 2017
• Study Start: June 20, 2017
• Primary Completion: June 20, 2020
• Study Completion: June 20, 2020
• Last Updated: July 21, 2017

Record last verified: 2017-07

Locations

FR (1)