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Cardiovascular Risk and Chronic Inflammatory Rheumatism (RCVRIC)

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ClinicalTrials.gov Identifier: NCT03187444
Recruitment Status : Recruiting
First Posted : June 15, 2017
Last Update Posted : June 15, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

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.

Condition or disease Intervention/treatment Phase
Rheumatology Cardiovascular Diseases Arthritis, Rheumatoid Spondyloarthritis Procedure: Examinations Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Intervention Model Description: all participants receive the same intervention throughout the protocol
Masking: None (Open Label)
Masking Description: Open
Primary Purpose: Other
Official Title: Cardiovascular Risk and Chronic Inflammatory Rheumatism
Actual Study Start Date : April 24, 2015
Estimated Primary Completion Date : October 24, 2036
Estimated Study Completion Date : April 4, 2037

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patients with chronic inflammatory rheumatism
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.
Procedure: Examinations
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 Measures :
  1. Change from baseline of the arterial Stiffness [ Time Frame: at 6 months, 12 months ]
    evaluated by the pulse wave velocity

  2. Change from baseline of resting heart rate [ Time Frame: at 6 months, 12 months ]
  3. Change from baseline of endothelial function [ Time Frame: at 6 months, 12 months ]
    by Tonometry

  4. Change from baseline of intima-media thickness and carotid and femoral atheroma [ Time Frame: at 5 years ]
  5. Change from baseline of autonomic nervous system activity [ Time Frame: at 6 months, 12 months ]
  6. Change from baseline of regional myocardial function [ Time Frame: at 6 months, 12 months ]
  7. 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

  8. Change from baseline of an abdominal aortic calcification score (DEXA) [ Time Frame: at 6 months, 12 months ]
  9. Change from baseline of hand muscle strength (Handgrip) [ Time Frame: at 6 months, 12 months ]
  10. 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)

  11. Change from baseline of food habits [ Time Frame: at 6 months, 12 months ]
    French FFQ questionnaire

  12. Change from baseline of body composition [ Time Frame: at 6 months, 12 months ]
    DEXA, pQCT

  13. Change from baseline of inflammatory rheumatism [ Time Frame: at 6 months, 12 months ]
    by the doctor in charge of the patient

  14. Change from baseline of depression (HAD) [ Time Frame: at 6 months, 12 months ]
  15. Change from baseline of fibromyalgia (FIRST) [ Time Frame: at 6 months, 12 months ]
  16. Change from baseline of the frequency of comorbidities during inflammatory rheumatism [ Time Frame: at 6 months, 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03187444


Contacts
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Contact: Partrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
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France
CHU de Clermont-Ferrand Recruiting
Clermont-Ferrand, Auvergne, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Principal Investigator: Martin SOUBRIER, PhD MD         
Sub-Investigator: Marion COUDERC         
Sub-Investigator: Jean Jacques DUBOST         
Sub-Investigator: Sandrine MALOCHET-GUINAMAND         
Sub-Investigator: Sylvain MATHIEU         
Sub-Investigator: Zuzana TATAR         
Sub-Investigator: Anne TOURNADRE         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
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Principal Investigator: Martin SOUBRIER, PhD MD CHU de Clermont-Ferrand

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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT03187444     History of Changes
Other Study ID Numbers: CHU-337
2014-A01847-40 ( Other Identifier: 2014-A01847-40 )
First Posted: June 15, 2017    Key Record Dates
Last Update Posted: June 15, 2017
Last Verified: June 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Clermont-Ferrand:
Cardiovascular risk
Chronic inflammatory rheumatism
Rheumatoid arthritis
Spondyloarthritis
Inflammation

Additional relevant MeSH terms:
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Streptococcal Infections
Arthritis
Cardiovascular Diseases
Spondylarthritis
Arthritis, Rheumatoid
Rheumatic Diseases
Collagen Diseases
Rheumatic Fever
Joint Diseases
Musculoskeletal Diseases
Spondylitis
Spinal Diseases
Bone Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Gram-Positive Bacterial Infections
Bacterial Infections