Evaluation and Management of Cardiovascular Risk Factors in Inflammatory and Acquired Dysimmune Diseases (CARMIN)

NCT02835547 | Completed

• 1 other identifier: D50841
• Study Type: observational
• Target: 600
• Locations: 0 countries
• Sites: N/A

Brief Summary

The hypothesis is that chronic inflammatory dysimmune state promotes the development of cardiovascular complications. The biological assumption is based on the fact that chronic inflammation promotes lesions of the vessel wall (endothelial alterations, calcification, atherosclerosis). The clinical aim is to allow to identify high-risk patients and to act in prevention. The project CARMIN involves the assessment of cardiovascular risk factors, their management, and their influence on cardiovascular prognosis in patients with autoimmune diseases and immunodeficiencies acquired. It is based on the creation and monitoring of a cohort of patients with different types of dysimmune disorders: systemic lupus erythematosus, rheumatoid arthritis, psoriasis, scleroderma, systemic vasculitis ANCA, kidney transplants, and hematopoietic stem cells transplants.

Conditions

Inflammatory and Acquired Dysimmune Diseases

Keywords

cardiovascular event; risk factors; inflammatory diseases and acquired dysimmune

Outcome Measures

Primary Outcomes (1)

• The occurrence of any cardiovascular event (will be recorded from the patient files and/or phone calls to patient")

  The cardiovascular events : cardiovascular death, myocardial infarction, stroke, peripheral arterial disease, ischemic manifestations in other territories, heart failure, arrhythmia, deep vein thrombosis or pulmonary embolism.

  2 years

Study Arms (6)

Systemic lupus erythematosus

Data collection of risk factors (collected retrospectively - 5 years) and cardiovascular events (collected prospectively - 2 years).

Other: Data collection

Rheumatoid arthritis

Data collection of risk factors (collected retrospectively - 5 years) and cardiovascular events (collected prospectively - 2 years).

Other: Data collection

Psoriasis

Data collection of risk factors (collected retrospectively - 5 years) and cardiovascular events (collected prospectively - 2 years).

Other: Data collection

Scleroderma

Data collection of risk factors (collected retrospectively - 5 years) and cardiovascular events (collected prospectively - 2 years).

Other: Data collection

Hematopoietic stem cells transplants

Data collection of risk factors (collected retrospectively - 5 years) and cardiovascular events (collected prospectively - 2 years).

Other: Data collection

Kidney transplants

Data collection of risk factors (collected retrospectively - 5 years) and cardiovascular events (collected prospectively - 2 years).

Other: Data collection

Interventions

Data collection OTHER

Risk factors will be collected retrospectively (5 years) and cardiovascular events prospectively (2 years)

Hematopoietic stem cells transplants; Kidney transplants; Psoriasis; Rheumatoid arthritis; Scleroderma; Systemic lupus erythematosus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with systemic lupus erythematosus, rheumatoid arthritis, psoriasis, scleroderma, kidney transplants, or hematopoietic stem cells transplants

You may qualify if:

• Patients followed in the various services of medical specialties pole of the Edouard Herriot hospital
• The diagnosis of the pathology selected for this study based on a clear clinical and biological evaluation supported by criteria specific to each pathology and compatible with international standards.
• Date of diagnosis should not be less than 5 years (+/- 1 year), except for scleroderma patients where it has been extended to 10 years.
• For kidney transplant patients the investigators take into account only patients with a maximum of 2 years of dialysis before graft.

You may not qualify if:

• Diabetic patients
• HIV seropositive
• Patients with multiple pathologies

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

MeSH Terms

Interventions

Data Collection

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

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

Study Record Dates

• First Submitted: June 21, 2016
• First Posted: July 18, 2016
• Study Start: February 1, 2009
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: July 18, 2016

Record last verified: 2016-07