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Study of Circulating Microparticles in Giant Cell Arteritis (MicroGiant)

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ClinicalTrials.gov Identifier: NCT02333708
Recruitment Status : Unknown
Verified September 2016 by University Hospital, Caen.
Recruitment status was:  Recruiting
First Posted : January 7, 2015
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen

Study Description
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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.

Condition or disease Intervention/treatment
Giant Cell Arteritis Acute Phase Other: Blood sample

Study Design
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Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Study of Circulating Microparticles in Giant Cell Arteritis
Study Start Date : September 2015
Estimated Primary Completion Date : September 16, 2018
Estimated Study Completion Date : November 2018

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Groups and Cohorts
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Group/Cohort Intervention/treatment
GCA group Other: Blood sample
Inflammatory syndrome (without GCA) group Other: Blood sample
Without inflammatory syndrome and without GCA group Other: Blood sample


Outcome Measures
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Primary Outcome Measures :
  1. Level of microparticles in the blood of patients with histologically proven giant cell arteritis. [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
primary and secondary care hospital
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
Contacts and Locations
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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): NCT02333708


Contacts
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Contact: Boris BIENVENU, MD, PhD, +33231064579 bienvenu-b@chu-caen.fr

Locations
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France
Centre Hospitalier Universitaire Côte de Nacre Recruiting
Caen, France, 14000
Contact: Boris BIENVENU    +33231064579      
Sponsors and Collaborators
University Hospital, Caen
More Information
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Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT02333708     History of Changes
Other Study ID Numbers: 2013-A00273-44
First Posted: January 7, 2015    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: September 2016
Additional relevant MeSH terms:
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Polymyalgia Rheumatica
Giant Cell Arteritis
Arteritis
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Vasculitis, Central Nervous System
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Cerebrovascular Disorders
 Brain Diseases
Central Nervous System Diseases
Skin Diseases, Vascular
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases