NCT02898467

Brief Summary

Intraplaque hemorrhage is the driving force of atherothrombotic plaque vulnerability to rupture and associated clinical complications. Polymorphonuclear neutrophils (PMNs) represent about 70% of leukocytes and may constitute a source of proteases and oxidants that favour plaque rupture. Our objective is to evaluate PMN activation in atherosclerotic plaque of non-diabetic versus type 2 diabetic patients. For this purpose, investigators will quantify the presence of cell-free DNA, that reflect the formation of neutrophil extracellular traps (NETs) in carotid endarterectomy samples.

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2016

Typical duration 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

First Submitted

Initial submission to the registry

September 8, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 13, 2016

Completed
18 days until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

September 13, 2016

Status Verified

September 1, 2016

Enrollment Period

2.1 years

First QC Date

September 8, 2016

Last Update Submit

September 12, 2016

Conditions

DiabetesAtherothrombosisCardiovascular Disease

Outcome Measures

Primary Outcomes (1)

  • Neutrophile activation assessed by free DNA levels in atherothrombotic plaques

    Ability of cfDNA concentration in the conditioned medium to discriminate atherothrombotic plaques from diabetic vs non-diabetic patients

    On day 1 (day of the surgery)

Secondary Outcomes (4)

  • Neutrophile activation assessed by other makers than free DNA levels in atherothrombotic plaques

    On day 1 (day of the surgery)

  • Intraplaque hemorrhage and oxidative stress assessed in plasma and aortic tissue

    From day 0 (day before the surgery) to day 1 (day of the surgery)

  • Correlation between plasma and atherothrombotic plaque markers assessement

    From day 0 (day before the surgery) to day 1 (day of the surgery)

  • Atherothrombosis characterization assessed by histological analysis

    On day 1 (day of the surgery)

Other Outcomes (1)

  • Banking of biological samples

    From day 0 (day before the surgery) to day 1 (day of the surgery)

Study Arms (2)

diabetics

Type 2 diabetic patients exhibiting fasting glycemia value over 7 mmol/L or glycated hemoglobin value over 6.5% or type 2 diabetic patients under oral anti-diabetic treatment or type 2 diabetic patient under insulin treatment and in which diabetes has been diagnosed after the age of 45 y

Other: diabetics

non-diabetics

patients without diagnosed diabetes exhibiting fasting glycemia value under 7 mmol/L

Other: non-diabetics

Interventions

diabeticsOTHER

additional blood and urine collection during usual medical care endarterectomy samples during usual medical care

diabetics
non-diabeticsOTHER

additional blood and urine collection during usual medical care endarterectomy samples during usual medical care

non-diabetics

Eligibility Criteria

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

Diabetics and non-diabetics with planned endartectomy

You may qualify if:

  • Adult patients with planned endarterectomy
  • Affiliated to social security rights
  • Signed inform consent

You may not qualify if:

  • pregnancy
  • Autoimmune disease, chronic inflammatory disease, neoplasia
  • Type 1 diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of endocrinology, University Hospital Reunion Island - Felix Guyon Site

Saint Denis de La Réunion, 97405, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

plasma and serum samples carotid endarterectomy samples urinary samples

MeSH Terms

Conditions

Diabetes MellitusThrombosisCardiovascular Diseases

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesEmbolism and ThrombosisVascular Diseases

Study Officials

  • XAVIER DEBUSSCHE, MD

    CHU DE LA REUNION

    PRINCIPAL INVESTIGATOR

Central Study Contacts

CHRISTINE JUHEL, PHD

CONTACT

+262262359949christine.juhel@chu-reunion.fr

Study Design

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

Study Record Dates

First Submitted

September 8, 2016

First Posted

September 13, 2016

Study Start

October 1, 2016

Primary Completion

November 1, 2018

Study Completion

June 1, 2019

Last Updated

September 13, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)