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

Completed

• Conditions: Inflammatory and Acquired Dysimmune Diseases
• Interventions: Other: Data collection

• Registration Number: NCT02835547
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Study First Submitted: 2016-06-21
• Status Verified: 2016-07
• Study First Submitted QC: 2016-07-15
• Last Update Submitted: 2016-07-15
• Study First Posted: 2016-07-18
• Last Update Posted: 2016-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• 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.

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Exclusion Criteria

• Diabetic patients
• HIV seropositive
• Patients with multiple pathologies

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Psoriasis	Data collection	Data collection of risk factors (collected retrospectively - 5 years) and cardiovascular events (collected prospectively - 2 years).
Rheumatoid arthritis	Data collection	Data collection of risk factors (collected retrospectively - 5 years) and cardiovascular events (collected prospectively - 2 years).
Systemic lupus erythematosus	Data collection	Data collection of risk factors (collected retrospectively - 5 years) and cardiovascular events (collected prospectively - 2 years).
Scleroderma	Data collection	Data collection of risk factors (collected retrospectively - 5 years) and cardiovascular events (collected prospectively - 2 years).
Hematopoietic stem cells transplants	Data collection	Data collection of risk factors (collected retrospectively - 5 years) and cardiovascular events (collected prospectively - 2 years).
Kidney transplants	Data collection	Data collection of risk factors (collected retrospectively - 5 years) and cardiovascular events (collected prospectively - 2 years).

Primary Outcome Measures

Name	Time	Method
The occurrence of any cardiovascular event (will be recorded from the patient files and/or phone calls to patient")	2 years	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.