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

July 15, 2016 updated by: Hospices Civils de Lyon

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

600

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (ACTUAL)

August 1, 2015

Study Completion (ACTUAL)

August 1, 2015

Study Registration Dates

First Submitted

June 21, 2016

First Submitted That Met QC Criteria

July 15, 2016

First Posted (ESTIMATE)

July 18, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

July 18, 2016

Last Update Submitted That Met QC Criteria

July 15, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • D50841

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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