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

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ClinicalTrials.gov Identifier: NCT02835547
Recruitment Status : Completed
First Posted : July 18, 2016
Last Update Posted : July 18, 2016
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Inflammatory and Acquired Dysimmune Diseases Other: Data collection

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Study Type : Observational
Actual Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation and Management of Cardiovascular Risk Factors in Inflammatory and Acquired Dysimmune Diseases (CARMIN)
Study Start Date : February 2009
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Group/Cohort Intervention/treatment
Systemic lupus erythematosus
Data collection of risk factors (collected retrospectively - 5 years) and cardiovascular events (collected prospectively - 2 years).
Other: Data collection
Risk factors will be collected retrospectively (5 years) and cardiovascular events prospectively (2 years)

Rheumatoid arthritis
Data collection of risk factors (collected retrospectively - 5 years) and cardiovascular events (collected prospectively - 2 years).
Other: Data collection
Risk factors will be collected retrospectively (5 years) and cardiovascular events prospectively (2 years)

Psoriasis
Data collection of risk factors (collected retrospectively - 5 years) and cardiovascular events (collected prospectively - 2 years).
Other: Data collection
Risk factors will be collected retrospectively (5 years) and cardiovascular events prospectively (2 years)

Scleroderma
Data collection of risk factors (collected retrospectively - 5 years) and cardiovascular events (collected prospectively - 2 years).
Other: Data collection
Risk factors will be collected retrospectively (5 years) and cardiovascular events prospectively (2 years)

Hematopoietic stem cells transplants
Data collection of risk factors (collected retrospectively - 5 years) and cardiovascular events (collected prospectively - 2 years).
Other: Data collection
Risk factors will be collected retrospectively (5 years) and cardiovascular events prospectively (2 years)

Kidney transplants
Data collection of risk factors (collected retrospectively - 5 years) and cardiovascular events (collected prospectively - 2 years).
Other: Data collection
Risk factors will be collected retrospectively (5 years) and cardiovascular events prospectively (2 years)




Primary Outcome Measures :
  1. The occurrence of any cardiovascular event (will be recorded from the patient files and/or phone calls to patient") [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with systemic lupus erythematosus, rheumatoid arthritis, psoriasis, scleroderma, kidney transplants, or hematopoietic stem cells transplants
Criteria

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.

Exclusion Criteria:

  • Diabetic patients
  • HIV seropositive
  • Patients with multiple pathologies

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02835547     History of Changes
Other Study ID Numbers: D50841
First Posted: July 18, 2016    Key Record Dates
Last Update Posted: July 18, 2016
Last Verified: July 2016
Keywords provided by Hospices Civils de Lyon:
cardiovascular event
risk factors
inflammatory diseases and acquired dysimmune