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Arachidonic Acid Metabolism in Carotid Stenosis Plaque in Diabetic Patients (MASCADI)

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ClinicalTrials.gov Identifier: NCT03202823
Recruitment Status : Recruiting
First Posted : June 29, 2017
Last Update Posted : July 31, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

Brief Summary:
Diabetes is associated with an increased risk of cardiovascular complications, as a reflection of the chronic inflammatory status. Monocytes-macrophages in diabetic subjects present impaired arachidonic acid metabolism. Moreover, atheromatous plaques in diabetic subjects seem to be significantly enriched in 2-AA-LPC (2-arachidonoyl-lysophosphatidylcholine) and are more inflammatory and more likely to rupture than are plaques in non-diabetic subjects. We therefore hypothesize that this vulnerability of atheromatous plaques in diabetic subjects could be explained by impaired 2-AA-LPC metabolism within the plaque.

Condition or disease Intervention/treatment
Carotid Stenosis Procedure: blood samples Procedure: recover samples of atheromatous plaque

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Arachidonic Acid Metabolism in Carotid Stenosis Plaque in Diabetic Patients
Actual Study Start Date : April 13, 2017
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : December 2020

Group/Cohort Intervention/treatment
Diabetics Procedure: blood samples
3 tubes (5 ml volume) collected during surgery

Procedure: recover samples of atheromatous plaque
a carotid sample collected during surgery

Non-diabetics Procedure: blood samples
3 tubes (5 ml volume) collected during surgery

Procedure: recover samples of atheromatous plaque
a carotid sample collected during surgery




Primary Outcome Measures :
  1. Change in arachidonic acid metabolism of atheromatous plaques from diabetic versus non-diabetic subjects [ Time Frame: Baseline ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Diabetic and non-diabetic patients with carotid stenosis who undergo surgery
Criteria

Inclusion Criteria:

  • Patients who have provided explicit consent
  • Patients older than 18 years
  • Patients about to undergo surgery for carotid stenosis
  • Haemoglobin ≥ 7g/dl at the time the sample is taken
  • Respect the maximum volume of blood taken (treatment + research) in 30 days

SPECIFIC TO DIABETICS

- Patients with type 1 or 2 diabetes diagnosed more than 6 months earlier

Exclusion Criteria:

  • Patients under guardianship
  • Patients without health insurance cover
  • Pregnant or breast-feeding women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03202823


Contacts
Contact: Eric STEINMETZ 03.80.29.33.52 eric.steinmetz@chu-dijon.fr

Locations
France
Chu Dijon Bourgogne Recruiting
Dijon, France, 21000
Contact: Eric STEINMETZ, MD    03.80.29.33.52    eric.steinmetz@chu-dijon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT03202823     History of Changes
Other Study ID Numbers: MENEGAUT 2016
First Posted: June 29, 2017    Key Record Dates
Last Update Posted: July 31, 2018
Last Verified: July 2018

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

Additional relevant MeSH terms:
Carotid Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases