Study of Circulating Microparticles in Giant Cell Arteritis

Giant Cell Arteritis Clinical Trial

— MicroGiant  

Official title:

Study of Circulating Microparticles in Giant Cell Arteritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02333708
• Other study ID #: 2013-A00273-44
• Status: Recruiting
• Start date: September 2015
• Est. completion date: November 2023

Study information

• Verified date: September 2016
• Source: University Hospital, Caen
• Contact: Boris BIENVENU, MD, PhD,
• Phone: +33231064579
• Email: bienvenu-b[@]chu-caen.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: November 2023
• Est. primary completion date: September 16, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Phase
• Arteritis
• Giant Cell Arteritis
• Polymyalgia Rheumatica

Intervention

Other:
• Blood sample

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire Côte de Nacre	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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