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

Sponsor
Hospices Civils de Lyon (Other)
Overall Status
Completed
CT.gov ID
NCT02835547
Collaborator
(none)
600
77.9

Study Details

Study Description

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 Phase
  • Other: Data collection

Study Design

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 :
Feb 1, 2009
Actual Primary Completion Date :
Aug 1, 2015
Actual Study Completion Date :
Aug 1, 2015

Arms and Interventions

Arm 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)

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT02835547
Other Study ID Numbers:
  • D50841
First Posted:
Jul 18, 2016
Last Update Posted:
Jul 18, 2016
Last Verified:
Jul 1, 2016

Study Results

No Results Posted as of Jul 18, 2016