RheumatologyRCVRICNCT03187444
Cardiovascular Risk and Chronic Inflammatory Rheumatism
A study testing Examinations in people with Rheumatology and Cardiovascular Diseases, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rheumatology, Cardiovascular Diseases, Arthritis, Rheumatoid
- What is being tested?
- Examinations
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 24 Apr 2015to 4 Apr 2037
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Examinations
- Keywords
- Cardiovascular risk, Chronic inflammatory rheumatism, Rheumatoid arthritis, Spondyloarthritis, Inflammation
- Medical subject headings
- Cardiovascular Diseases, Arthritis, Rheumatoid, Spondylarthritis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExaminationsProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with chronic inflammatory rheumatism | Experimental | 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. Receives: Procedure: Examinations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of the arterial Stiffness
evaluated by the pulse wave velocity
Measured: at 6 months, 12 months
Change from baseline of resting heart rate
Measured: at 6 months, 12 months
Change from baseline of endothelial function
by Tonometry
Measured: at 6 months, 12 months
Change from baseline of intima-media thickness and carotid and femoral atheroma
Measured: at 5 years
Change from baseline of autonomic nervous system activity
Measured: at 6 months, 12 months
Change from baseline of regional myocardial function
Measured: at 6 months, 12 months
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
Measured: at 6 months, 12 months
Change from baseline of an abdominal aortic calcification score (DEXA)
Measured: at 6 months, 12 months
Change from baseline of hand muscle strength (Handgrip)
Measured: at 6 months, 12 months
Change from baseline of energy expenditure and physical activity in usual living conditions
by Android application on smartphone (eMeetingSearch)
Measured: at 6 months, 12 months
Change from baseline of food habits
French FFQ questionnaire
Measured: at 6 months, 12 months
Change from baseline of body composition
DEXA, pQCT
Measured: at 6 months, 12 months
Change from baseline of inflammatory rheumatism
by the doctor in charge of the patient
Measured: at 6 months, 12 months
Change from baseline of depression (HAD)
Measured: at 6 months, 12 months
Change from baseline of fibromyalgia (FIRST)
Measured: at 6 months, 12 months
Change from baseline of the frequency of comorbidities during inflammatory rheumatism
Measured: at 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2017
- Study start24 Apr 2015
- Primary completion24 Oct 2036 (estimated)
- Study completion4 Apr 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RheumatologyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- all participants receive the same intervention throughout the protocol
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin SOUBRIER, PhD MD, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03187444
- Sponsor's protocol ID
- CHU-337
- Other IDs
- 2014-A01847-40
- Acronym
- RCVRIC
- Status last verified
- Jun 2017
- First submitted
- 7 Jun 2017
- Last updated
- 25 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Risk and Chronic Inflammatory Rheumatism
- ClinicalTrials.gov ID
- NCT03187444
- Acronym / sponsor ID
- RCVRIC / CHU-337
- Keywords
- Cardiovascular risk, Chronic inflammatory rheumatism, Rheumatoid arthritis, Spondyloarthritis, Inflammation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 24 Apr 2015 (actual)
- Primary completion
- 24 Oct 2036 (estimated)
- Study completion
- 4 Apr 2037 (estimated)
- First posted
- 15 Jun 2017 (actual)
- 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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- all participants receive the same intervention throughout the protocol
| Arm | Type | Receives |
|---|---|---|
| Patients with chronic inflammatory rheumatism | Experimental | Procedure: ExaminationsAll 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
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 |
|---|---|---|
| ExaminationsSeveral examinations are realized on each patients, in addition to the usual visit and after verification of the criteria of inclusion and signature of consent. | Procedure or surgery | Patients with chronic inflammatory rheumatism |
Primary outcome
Change from baseline of the arterial Stiffness
Time frame: at 6 months, 12 months
evaluated by the pulse wave velocity
Change from baseline of resting heart rate
Time frame: at 6 months, 12 months
Change from baseline of endothelial function
Time frame: at 6 months, 12 months
by Tonometry
Change from baseline of intima-media thickness and carotid and femoral atheroma
Time frame: at 5 years
Change from baseline of autonomic nervous system activity
Time frame: at 6 months, 12 months
Change from baseline of regional myocardial function
Time frame: at 6 months, 12 months
Change from baseline of other markers of cardiovascular risk
Time frame: at 6 months, 12 months
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)
Time frame: at 6 months, 12 months
Change from baseline of hand muscle strength (Handgrip)
Time frame: at 6 months, 12 months
Change from baseline of energy expenditure and physical activity in usual living conditions
Time frame: at 6 months, 12 months
by Android application on smartphone (eMeetingSearch)
Change from baseline of food habits
Time frame: at 6 months, 12 months
French FFQ questionnaire
Change from baseline of body composition
Time frame: at 6 months, 12 months
DEXA, pQCT
Change from baseline of inflammatory rheumatism
Time frame: at 6 months, 12 months
by the doctor in charge of the patient
Change from baseline of depression (HAD)
Time frame: at 6 months, 12 months
Change from baseline of fibromyalgia (FIRST)
Time frame: at 6 months, 12 months
Change from baseline of the frequency of comorbidities during inflammatory rheumatism
Time frame: at 6 months, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
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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.
Martin SOUBRIER, PhD MD principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Examinations in people with Rheumatology and Cardiovascular Diseases, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 7 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
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?
Change from baseline of the arterial Stiffness (time frame: at 6 months, 12 months). The study lists 16 primary outcomes in all. 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 25 May 2022.