NCT02804659

Brief Summary

Molecular analysis of the atheroma plaque. Screening for a novel biomarker of carotid status.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

June 15, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 17, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

August 10, 2018

Status Verified

August 1, 2018

Enrollment Period

5.7 years

First QC Date

June 15, 2016

Last Update Submit

August 9, 2018

Conditions

Carotid Arteries

Keywords

micro-RNA

Outcome Measures

Primary Outcomes (1)

  • expression level of the seven miRNAs of interest

    expression level of the seven miRNAs of interest in the serum and in carotid artery plaques : miR-100, miR-125a, miR-127, miR-133a, miR-145, miR-221

    Day of surgery

Interventions

microRNAOTHER

Extraction of the microRNA using the mirVana miRNA isolation kit and quantification using real-time PCRs

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults having to undergo carotid thrombendarteriectomy

You may qualify if:

  • Adults having to undergo carotid thromboendarteriectomy
  • social security coverage
  • provision of study information
  • consent to participation.

You may not qualify if:

  • Previous carotid artery surgery
  • refusal to participate in the study
  • or inability to give consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, 80054, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

carotid artery plaques blood

MeSH Terms

Interventions

MicroRNAs

Intervention Hierarchy (Ancestors)

RNA, AntisenseAntisense Elements (Genetics)Nucleic Acids, Nucleotides, and NucleosidesRNANucleic AcidsRNA, Small UntranslatedRNA, Untranslated

Study Officials

  • Pierre MAITRIAS, PhD

    CHU Amiens

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierre MAITRIAS, PhD

CONTACT

+33 3 22 08 72 67maitrias.pierre@chu-amiens.fr

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2016

First Posted

June 17, 2016

Study Start

July 1, 2013

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

August 10, 2018

Record last verified: 2018-08

Locations

FR(1)