Cardiovascular Risk and Chronic Inflammatory Rheumatism (RCVRIC)
Primary Purpose
Rheumatology, Cardiovascular Diseases, Arthritis, Rheumatoid
Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Examinations
Sponsored by
About this trial
This is an interventional other trial for Rheumatology focused on measuring Cardiovascular risk, Chronic inflammatory rheumatism, Rheumatoid arthritis, Spondyloarthritis, Inflammation
Eligibility Criteria
Inclusion Criteria:
- Being older than 18 years
- Have rheumatoid arthritis or spondyloarthritis (ankylosing spondylitis, psoriatic arthritis)
- Receive first conventional DMARD or biological treatment (anti-TNF, Abatacept, Tocilizumab, rituximab) for patients with rheumatoid arthritis
- Receive biological treatment (Abatacept, Tocilizumab, rituximab) for patients with rheumatoid arthritis who have failed anti-TNF treatment.
- Receive first NSAID (optionally combined with conventional DMARDs in case of peripheral arthritis) or biological treatment (anti-TNF, Usketinumab) for patients with spondyloarthritis.
- Being subject to a social security scheme
- Have the capacity to give informed consent and to comply with the study requirements
Exclusion Criteria:
- Patient refused to sign the consent form
- Patient under guardianship
- Patient having already been exposed to a biological as part of its pathology
- Patient with chronic disease may interfere with cardiovascular disease either by itself or by treatment history
- For echocardiography high resolution STI: Patients with hypertension, diabetes and cardiovascular history.
- To evaluate the activity of the autonomic nervous system, patients with hypertension, diabetics, with cardiovascular history with a neurological disease, with vasoactive or chronotropic treatments such as beta-blockers, antiarrhythmics, antihypertensives, anxiolytics, antidepressants
- Pregnant or lactating women will be temporarily excluded from the study during the period of pregnancy and breastfeeding.
Sites / Locations
- CHU de Clermont-Ferrand
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with chronic inflammatory rheumatism
Arm Description
All patients over 18 years, with rheumatoid arthritis treated for the first time with conventional anti-TNF therapy, Abatacept, Tocilizumab, Rituximab or patients with spondyloarthritis treated for the first time with NSAIDs that may be associated with conventional background treatments for peripheral or biological (anti-TNF, Usketinumab) may be included.
Outcomes
Primary Outcome Measures
Change from baseline of the arterial Stiffness
evaluated by the pulse wave velocity
Change from baseline of resting heart rate
Change from baseline of endothelial function
by Tonometry
Change from baseline of intima-media thickness and carotid and femoral atheroma
Change from baseline of autonomic nervous system activity
Change from baseline of regional myocardial function
Change from baseline of other markers of cardiovascular risk
troponin, NT_proBNP, adipocytokines, MCP-1, assymetric dimethylaarginine, angiopoietin-2, anti apo A-1, IL-6, IL-17
Change from baseline of an abdominal aortic calcification score (DEXA)
Change from baseline of hand muscle strength (Handgrip)
Change from baseline of energy expenditure and physical activity in usual living conditions
by Android application on smartphone (eMeetingSearch)
Change from baseline of food habits
French FFQ questionnaire
Change from baseline of body composition
DEXA, pQCT
Change from baseline of inflammatory rheumatism
by the doctor in charge of the patient
Change from baseline of depression (HAD)
Change from baseline of fibromyalgia (FIRST)
Change from baseline of the frequency of comorbidities during inflammatory rheumatism
Secondary Outcome Measures
Full Information
NCT ID
NCT03187444
First Posted
June 7, 2017
Last Updated
May 24, 2022
Sponsor
University Hospital, Clermont-Ferrand
1. Study Identification
Unique Protocol Identification Number
NCT03187444
Brief Title
Cardiovascular Risk and Chronic Inflammatory Rheumatism
Acronym
RCVRIC
Official Title
Cardiovascular Risk and Chronic Inflammatory Rheumatism
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 24, 2015 (Actual)
Primary Completion Date
October 24, 2036 (Anticipated)
Study Completion Date
April 4, 2037 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Chronic inflammatory rheumatism and inflammation can increase the risk of cardiovascular problems. Indeed, these diseases can increase the risk of myocardial infarction. The objective of this project is a better understanding and preventing the risk of cardiovascular problems in chronic inflammatory rheumatism through the study on the long-term flexibility of the arteries, blood markers of cardiovascular risk and muscle mass.
Detailed Description
All patients over 18 years, with rheumatoid arthritis treated for the first time with conventional anti-TNF therapy, Abatacept, Tocilizumab, Rituximab or patients with spondyloarthritis treated for the first time with NSAIDs that may be associated with conventional background treatments for peripheral or biological (anti-TNF, Usketinumab) may be included. However, they must be subject to a Social Security scheme and will only be able to participate in the research if they give their consent in writing after receiving full information.
In addition to the usual visit and after verification of the criteria of inclusion and signature of consent, arterial stiffness and endothelial function measurement are performed at M0, M6, M12 and every year and also at each change of treatment, By measuring the pulse wave velocity and by determining the Alx by the SphygmoCor XCEL (AtCor Medical Pty Ltd, based in Australia (CE 0120). Cardiac Frequency at rest will be evaluated at M0, M6, M12, every year and also at each change of treatment, by the realization of an electrocardiogram. The intima-media thickness (EIM) of the carotid will be evaluated every 5 years According to the recommendation. EIM is a non-invasive ultrasound technique in which an ultrasound probe is placed opposite the right primitive carotid artery by convention. A measurement of endothelial function will be performed at M0, M6, M12 and then every year in patients
A study of regional myocardial function by high-resolution echocardiography-STI will be carried out at M0, M6, M12 and then every year in non-hypertensive patients, without diabetes, without a cardiovascular history.
A Serum / plasma / urine bank will be constituted at M0, M6, M12, every year and also at each change of treatment to determine the markers of cardiovascular risk. The plasma bank will be used for the determination of nitric oxide.
A study of the body composition dual-energy x-ray absorptiometry (DXA) and pQCT allowing to evaluate lean mass, fat mass and bone mineral mass will be carried out at M0, then every year and also at each change of treatment M6 assessment of lean mass and fat mass only). When DXA is examined, a lateral incidence measurement of the rachis will be performed to calculate an arterial calcification score.
Muscle strength will be measured by hydraulic hand dynamometer Jamar (Kinetec company) at M0, M6, M12 then every year and also at each change of treatment. Physical performances will be evaluated by a 6-minute walking test, 10 meters walking speed and "Timed up-and-go test" stool test, which combines both coordination mechanisms, proprioception and muscular strength of lower limbs than M0, M6, M12 and then every year and also with each change of treatment.
The physical activity and physical inactivity of the patient and food habits will be assessed by the GPAQ (Global Physical Activity Questionnaire), FFQ and a Food questionnaire to M0, M6, M12 and every year and also to each change of treatment .
Depression will be assessed by the HAD self-administered questionnaire at M0, M6, M12 and then every year and also at each change of treatment.
Fibromyalgia will be assessed by the Fibromyalgia Rapid Screening Tool at M0, M6, M12 and then annually.
Comorbidities will be assessed by a nurse at M0, M12 and then annually.
All these examinations will be carried out in addition to the usual follow-up.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatology, Cardiovascular Diseases, Arthritis, Rheumatoid, Spondyloarthritis
Keywords
Cardiovascular risk, Chronic inflammatory rheumatism, Rheumatoid arthritis, Spondyloarthritis, Inflammation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
all participants receive the same intervention throughout the protocol
Masking
None (Open Label)
Masking Description
Open
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with chronic inflammatory rheumatism
Arm Type
Experimental
Arm Description
All patients over 18 years, with rheumatoid arthritis treated for the first time with conventional anti-TNF therapy, Abatacept, Tocilizumab, Rituximab or patients with spondyloarthritis treated for the first time with NSAIDs that may be associated with conventional background treatments for peripheral or biological (anti-TNF, Usketinumab) may be included.
Intervention Type
Procedure
Intervention Name(s)
Examinations
Intervention Description
Several examinations are realized on each patients, in addition to the usual visit and after verification of the criteria of inclusion and signature of consent.
Primary Outcome Measure Information:
Title
Change from baseline of the arterial Stiffness
Description
evaluated by the pulse wave velocity
Time Frame
at 6 months, 12 months
Title
Change from baseline of resting heart rate
Time Frame
at 6 months, 12 months
Title
Change from baseline of endothelial function
Description
by Tonometry
Time Frame
at 6 months, 12 months
Title
Change from baseline of intima-media thickness and carotid and femoral atheroma
Time Frame
at 5 years
Title
Change from baseline of autonomic nervous system activity
Time Frame
at 6 months, 12 months
Title
Change from baseline of regional myocardial function
Time Frame
at 6 months, 12 months
Title
Change from baseline of other markers of cardiovascular risk
Description
troponin, NT_proBNP, adipocytokines, MCP-1, assymetric dimethylaarginine, angiopoietin-2, anti apo A-1, IL-6, IL-17
Time Frame
at 6 months, 12 months
Title
Change from baseline of an abdominal aortic calcification score (DEXA)
Time Frame
at 6 months, 12 months
Title
Change from baseline of hand muscle strength (Handgrip)
Time Frame
at 6 months, 12 months
Title
Change from baseline of energy expenditure and physical activity in usual living conditions
Description
by Android application on smartphone (eMeetingSearch)
Time Frame
at 6 months, 12 months
Title
Change from baseline of food habits
Description
French FFQ questionnaire
Time Frame
at 6 months, 12 months
Title
Change from baseline of body composition
Description
DEXA, pQCT
Time Frame
at 6 months, 12 months
Title
Change from baseline of inflammatory rheumatism
Description
by the doctor in charge of the patient
Time Frame
at 6 months, 12 months
Title
Change from baseline of depression (HAD)
Time Frame
at 6 months, 12 months
Title
Change from baseline of fibromyalgia (FIRST)
Time Frame
at 6 months, 12 months
Title
Change from baseline of the frequency of comorbidities during inflammatory rheumatism
Time Frame
at 6 months, 12 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Being older than 18 years
Have rheumatoid arthritis or spondyloarthritis (ankylosing spondylitis, psoriatic arthritis)
Receive first conventional DMARD or biological treatment (anti-TNF, Abatacept, Tocilizumab, rituximab) for patients with rheumatoid arthritis
Receive biological treatment (Abatacept, Tocilizumab, rituximab) for patients with rheumatoid arthritis who have failed anti-TNF treatment.
Receive first NSAID (optionally combined with conventional DMARDs in case of peripheral arthritis) or biological treatment (anti-TNF, Usketinumab) for patients with spondyloarthritis.
Being subject to a social security scheme
Have the capacity to give informed consent and to comply with the study requirements
Exclusion Criteria:
Patient refused to sign the consent form
Patient under guardianship
Patient having already been exposed to a biological as part of its pathology
Patient with chronic disease may interfere with cardiovascular disease either by itself or by treatment history
For echocardiography high resolution STI: Patients with hypertension, diabetes and cardiovascular history.
To evaluate the activity of the autonomic nervous system, patients with hypertension, diabetics, with cardiovascular history with a neurological disease, with vasoactive or chronotropic treatments such as beta-blockers, antiarrhythmics, antihypertensives, anxiolytics, antidepressants
Pregnant or lactating women will be temporarily excluded from the study during the period of pregnancy and breastfeeding.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin SOUBRIER, PhD MD
Organizational Affiliation
CHU de Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Clermont-Ferrand
City
Clermont-Ferrand
State/Province
Auvergne
ZIP/Postal Code
63003
Country
France
12. IPD Sharing Statement
Learn more about this trial
Cardiovascular Risk and Chronic Inflammatory Rheumatism
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