Study of Circulating Microparticles in Giant Cell Arteritis

NCT ID: NCT02333708

Last Updated: 2022-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2023-11-30

Brief Summary

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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

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Conditions

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Giant Cell Arteritis Acute Phase

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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GCA group

Blood sample

Intervention Type OTHER

Inflammatory syndrome (without GCA) group

Blood sample

Intervention Type OTHER

Without inflammatory syndrome and without GCA group

Blood sample

Intervention Type OTHER

Interventions

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Blood sample

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre Hospitalier Universitaire Côte de Nacre

Caen, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Boris BIENVENU, MD, PhD,

Role: CONTACT

+33231064579

Facility Contacts

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Boris BIENVENU

Role: primary

+33231064579

Other Identifiers

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2013-A00273-44

Identifier Type: -

Identifier Source: org_study_id

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