Inflammatory and Acquired Dysimmune DiseasesCARMINNCT02835547
Evaluation and Management of Cardiovascular Risk Factors in Inflammatory and Acquired Dysimmune Diseases (CARMIN)
An observational study of Inflammatory and Acquired Dysimmune Diseases, run by Hospices Civils de Lyon.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory and Acquired Dysimmune Diseases
- What is being tested?
- Data collection
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- Feb 2009to Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with systemic lupus erythematosus, rheumatoid arthritis, psoriasis, scleroderma, kidney transplants, or hematopoietic stem cells transplants
Who may be able to join
- 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.
Who cannot join
- Diabetic patients
- HIV seropositive
- Patients with multiple pathologies
About this study
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.
- Being tested
- Data collection
- Keywords
- cardiovascular event, risk factors, inflammatory diseases and acquired dysimmune
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
Risk factors will be collected retrospectively (5 years) and cardiovascular events prospectively (2 years)
| Study group | Role | What they receive |
|---|---|---|
| Systemic lupus erythematosus | Data collection of risk factors (collected retrospectively - 5 years) and cardiovascular events (collected prospectively - 2 years). Receives: Other: Data collection | |
| Rheumatoid arthritis | Data collection of risk factors (collected retrospectively - 5 years) and cardiovascular events (collected prospectively - 2 years). Receives: Other: Data collection | |
| Psoriasis | Data collection of risk factors (collected retrospectively - 5 years) and cardiovascular events (collected prospectively - 2 years). Receives: Other: Data collection | |
| Scleroderma | Data collection of risk factors (collected retrospectively - 5 years) and cardiovascular events (collected prospectively - 2 years). Receives: Other: Data collection | |
| Hematopoietic stem cells transplants | Data collection of risk factors (collected retrospectively - 5 years) and cardiovascular events (collected prospectively - 2 years). Receives: Other: Data collection | |
| Kidney transplants | Data collection of risk factors (collected retrospectively - 5 years) and cardiovascular events (collected prospectively - 2 years). Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrence of any cardiovascular event (will be recorded from the patient files and/or phone calls to patient")
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2016 (estimated)
- Study startFeb 2009
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory and Acquired Dysimmune DiseasesStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02835547
- Sponsor's protocol ID
- D50841
- Acronym
- CARMIN
- Status last verified
- Jul 2016
- First submitted
- 21 Jun 2016
- Last updated
- 18 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Management of Cardiovascular Risk Factors in Inflammatory and Acquired Dysimmune Diseases (CARMIN)
- ClinicalTrials.gov ID
- NCT02835547
- Acronym / sponsor ID
- CARMIN / D50841
- Keywords
- cardiovascular event, risk factors, inflammatory diseases and acquired dysimmune
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 18 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Systemic lupus erythematosus | – | Other: Data collectionData collection of risk factors (collected retrospectively - 5 years) and cardiovascular events (collected prospectively - 2 years). |
| Rheumatoid arthritis | – | Other: Data collectionData collection of risk factors (collected retrospectively - 5 years) and cardiovascular events (collected prospectively - 2 years). |
| Psoriasis | – | Other: Data collectionData collection of risk factors (collected retrospectively - 5 years) and cardiovascular events (collected prospectively - 2 years). |
| Scleroderma | – | Other: Data collectionData collection of risk factors (collected retrospectively - 5 years) and cardiovascular events (collected prospectively - 2 years). |
| Hematopoietic stem cells transplants | – | Other: Data collectionData collection of risk factors (collected retrospectively - 5 years) and cardiovascular events (collected prospectively - 2 years). |
| Kidney transplants | – | Other: Data collectionData collection of risk factors (collected retrospectively - 5 years) and cardiovascular events (collected prospectively - 2 years). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with systemic lupus erythematosus, rheumatoid arthritis, psoriasis, scleroderma, kidney transplants, or hematopoietic stem cells transplants
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Diabetic patients
- HIV seropositive
- Patients with multiple pathologies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collectionRisk factors will be collected retrospectively (5 years) and cardiovascular events prospectively (2 years) | Other | Hematopoietic stem cells transplants, Kidney transplants, Psoriasis, Rheumatoid arthritis, Scleroderma, Systemic lupus erythematosus |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory and Acquired Dysimmune Diseases, run by Hospices Civils de Lyon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The occurrence of any cardiovascular event (will be recorded from the patient files and/or phone calls to patient") (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2016.