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Study of Circulating Microparticles in Giant Cell Arteritis (MicroGiant)

C

Caen University Hospital

Status

Unknown

Conditions

Giant Cell Arteritis
Acute Phase

Treatments

Other: Blood sample

Study type

Observational

Funder types

Other

Identifiers

NCT02333708
2013-A00273-44

Details and patient eligibility

About

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.

Enrollment

75 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

For GCA group:

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

Trial design

75 participants in 3 patient groups

GCA group
Treatment:
Other: Blood sample
Inflammatory syndrome (without GCA) group
Treatment:
Other: Blood sample
Without inflammatory syndrome and without GCA group
Treatment:
Other: Blood sample

Trial contacts and locations

1

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Central trial contact

Boris BIENVENU, MD, PhD,

Data sourced from clinicaltrials.gov

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