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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

Tracking Information
First Submitted Date June 21, 2016
First Posted Date July 18, 2016
Last Update Posted Date July 18, 2016
Study Start Date February 2009
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 15, 2016)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation and Management of Cardiovascular Risk Factors in Inflammatory and Acquired Dysimmune Diseases (CARMIN)
Official Title Evaluation and Management of Cardiovascular Risk Factors in Inflammatory and Acquired Dysimmune Diseases (CARMIN)
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with systemic lupus erythematosus, rheumatoid arthritis, psoriasis, scleroderma, kidney transplants, or hematopoietic stem cells transplants
Condition Inflammatory and Acquired Dysimmune Diseases
Intervention Other: Data collection
Risk factors will be collected retrospectively (5 years) and cardiovascular events prospectively (2 years)
Study Groups/Cohorts
  • Systemic lupus erythematosus
    Data collection of risk factors (collected retrospectively - 5 years) and cardiovascular events (collected prospectively - 2 years).
    Intervention: Other: Data collection
  • Rheumatoid arthritis
    Data collection of risk factors (collected retrospectively - 5 years) and cardiovascular events (collected prospectively - 2 years).
    Intervention: Other: Data collection
  • Psoriasis
    Data collection of risk factors (collected retrospectively - 5 years) and cardiovascular events (collected prospectively - 2 years).
    Intervention: Other: Data collection
  • Scleroderma
    Data collection of risk factors (collected retrospectively - 5 years) and cardiovascular events (collected prospectively - 2 years).
    Intervention: Other: Data collection
  • Hematopoietic stem cells transplants
    Data collection of risk factors (collected retrospectively - 5 years) and cardiovascular events (collected prospectively - 2 years).
    Intervention: Other: Data collection
  • Kidney transplants
    Data collection of risk factors (collected retrospectively - 5 years) and cardiovascular events (collected prospectively - 2 years).
    Intervention: Other: Data collection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 15, 2016)
600
Original Actual Enrollment Same as current
Actual Study Completion Date August 2015
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02835547
Other Study ID Numbers D50841
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Hospices Civils de Lyon
Study Sponsor Hospices Civils de Lyon
Collaborators Not Provided
Investigators Not Provided
PRS Account Hospices Civils de Lyon
Verification Date July 2016