NCT03149406

Brief Summary

Carotid stenosis of atherosclerotic origin may be responsible for stroke, which is one of the most important causes of morbidity and mortality in the Western world

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
245

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2012

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

December 26, 2012

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

May 4, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 11, 2017

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 26, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 26, 2020

Completed
Last Updated

August 3, 2018

Status Verified

August 1, 2018

Enrollment Period

8 years

First QC Date

May 4, 2017

Last Update Submit

August 2, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Analysis of the miRNAs

    by PCR of the composition of the atheroma plaque

    3 years

Study Arms (2)

Symptomatic patients

in the department with carotid plaque Comparing the expression of miRNAs

Other: Comparing the expression of miRNAs

Asymptomatic patients

in consultation with carotid plaque Comparing the expression of miRNAs

Other: Comparing the expression of miRNAs

Interventions

by PCR, in symptomatic and asymptomatic carotid plaques.

Asymptomatic patientsSymptomatic patients

Eligibility Criteria

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

Symptomatic patients in the service, and asymptomatic in consultation with carotid atheroma plaque

You may qualify if:

  • Any adult with a carotid thrombo endarterectomy,
  • affiliated to a social security scheme,
  • informed of the study and not opposed to it.

You may not qualify if:

  • Any person benefiting from an iterative carotid surgery,
  • or refusing to participate in the study,
  • or not being able to express its consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens Picardie

Amiens, Picardie, 80054, France

RECRUITING

Study Officials

  • Thierry REIX, PhD

    CHU AMIENS-PICARDIE

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

May 4, 2017

First Posted

May 11, 2017

Study Start

December 26, 2012

Primary Completion

December 26, 2020

Study Completion

December 26, 2020

Last Updated

August 3, 2018

Record last verified: 2018-08

Locations