Study of Circulating Microparticles in Giant Cell Arteritis

NCT02333708 | Unknown

• 1 other identifier: 2013-A00273-44
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Giant Cell Arteritis; Acute Phase

Outcome Measures

Primary Outcomes (1)

• Level of microparticles in the blood of patients with histologically proven giant cell arteritis.

  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.

  Baseline

Study Arms (3)

GCA group

Other: Blood sample

Inflammatory syndrome (without GCA) group

Other: Blood sample

Without inflammatory syndrome and without GCA group

Other: Blood sample

Interventions

Blood sample OTHER

GCA group; Inflammatory syndrome (without GCA) group; Without inflammatory syndrome and without GCA group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

primary and secondary care hospital

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

Centre Hospitalier Universitaire Côte de Nacre

Caen, 14000, France

RECRUITING

MeSH Terms

Conditions

Giant Cell Arteritis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Vasculitis, Central Nervous System; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arteritis; Vasculitis; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Boris BIENVENU, MD, PhD,

CONTACT

+33231064579; bienvenu-b@chu-caen.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2015
• First Posted: January 7, 2015
• Study Start: September 1, 2015
• Primary Completion: September 16, 2023
• Study Completion: November 1, 2023
• Last Updated: March 9, 2022

Record last verified: 2016-09

Locations

FR (1)