MicroGiant: Study of Circulating Microparticles in Giant Cell Arteritis

• Sponsor: University Hospital, Caen (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT02333708
• Collaborator: (none)
• Enrollment: 75
• Location: 1
• Duration (Months): 98
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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	Phase
Giant Cell Arteritis; Acute Phase	Other: Blood sample

Study Design

• Study Type: Observational
• Anticipated Enrollment: 75 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Study of Circulating Microparticles in Giant Cell Arteritis
• Study Start Date: Sep 1, 2015
• Anticipated Primary Completion Date: Sep 16, 2023
• Anticipated Study Completion Date: Nov 1, 2023

Arms and Interventions

Arm	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

Primary Outcome Measures

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

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalier Universitaire Côte de Nacre	Caen		France	14000

Sponsors and Collaborators

• University Hospital, Caen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Caen
• ClinicalTrials.gov Identifier: NCT02333708
• Other Study ID Numbers: 2013-A00273-44
• First Posted: Jan 7, 2015
• Last Update Posted: Mar 9, 2022
• Last Verified: Sep 1, 2016

• Additional relevant MeSH terms: Polymyalgia Rheumatica; Giant Cell Arteritis; Arteritis

Study Results

No Results Posted as of Mar 9, 2022