Study of Circulating Microparticles in Giant Cell Arteritis

• Conditions: Giant Cell Arteritis; Acute Phase
• Interventions: Other: Blood sample

• Registration Number: NCT02333708
• Lead Sponsor: University Hospital, Caen

Brief Summary

To demonstrate that microparticles (MPs), having a powerful procoagulant potential, are in larger amounts in the blood of patients with histologically proven giant cell arteritis (GCA), compared with patients matched for age, sex and with or without inflammatory syndrome.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-05
• Study First Submitted QC: 2015-01-06
• Study First Posted: 2015-01-07
• Study Start: 2015-09
• Status Verified: 2016-09
• Last Update Submitted: 2022-03-08
• Last Update Posted: 2022-03-09
• Primary Completion: 2023-09-16
• Study Completion: 2023-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• Men and women ≥ 18 years of age Patient affiliated to social security regimen

• Informed and having signed the consent form to take part in the study.

• Diagnosis of GCA, meeting at least 3 of the following 5 American College of Rheumatology (ACR) criteria for the diagnosis of GCA, including inflammatory syndrome and having

  • Either temporal artery biopsy showing characteristic GCA abnormality
  • Or inflammatory arteritis on imaging examination

Exclusion Criteria

• Persons under protection of the court or guardianship
• Inability to understand or to follow study procedures
• Dementia
• cancer diagnosed within the previous 5 years (except for non-melanoma skin cancer or in situ carcinoma of the cervix)non-contributory or inconclusive temporal artery biopsy
• Any conditions that might interfere with MPs level: diabetes, recent endo-arterial gesture, current treatment with corticosteroids.
• Participation in another ongoing clinical trial Current anticoagulant therapy
• Active infectious disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
GCA group	Blood sample	-
Without inflammatory syndrome and without GCA group	Blood sample	-
Inflammatory syndrome (without GCA) group	Blood sample	-

Primary Outcome Measures

Name	Time	Method
Level of microparticles in the blood of patients with histologically proven giant cell arteritis.	Baseline	Level of microparticles (MPs) in the blood of patients with histologically proven giant cell arteritis (GCA), compared with patients matched for age, sex and with or without inflammatory syndrome.

Trial Locations

Locations (1)

Centre Hospitalier Universitaire Côte de Nacre; 🇫🇷 Caen, France