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Study on vascular stiffness using carotid-femoral pulse wave velocity (cfPWV) in patients with systemic inflammatory rheumatic diseases and chronic pain syndromes.

Recruiting
Conditions
Patients with systemic inflammatory rheumatic diseases (collagenoses, vasculitides, arthritides) and chronic pain syndromes (fibromyalgia syndrome, somatization disorders).
M00-M25
M30-M36
M05-M14
M45-M49
M60-M63
M79
F45
I77
Arthropathies
Registration Number
DRKS00031470
Lead Sponsor
Rheumazentrum Rheinland-Pfalz GmbH
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
570
Inclusion Criteria

Eligible control subjects and patients of the Rheumatism Center Rhineland-Palatinate and the cooperating centers; patients fulfill the respective established classification criteria of the American College of Rheumatology (ACR) '' or the ''European League against Rheumatism (EULAR)'' for the investigated collagenoses, spondyloarthropathies, arthritides, vasculitides, wear diseases and chronic pain syndromes. A written informed consent of the patients is a prerequisite for the execution of the trial.

Exclusion Criteria

Patients with malignant diseases; minor patients; patients who refuse the examination; lack of capacity to consent or doubts about capacity to consent.

Study & Design

Study Type
observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Aortic vascular stiffness measured using carotid-femoral pulse wave velocity (cfPWFV).
Secondary Outcome Measures
NameTimeMethod
Assessment of the vascular situation by carotid ultrasonography, nailfold capillaroscopy (NVC), and retinal vessel analysis (RVA).<br><br>Retrospective analysis of the following parameters and scores of disease activity:<br>C3c, C4, dsDNA, ANA, CRP, ESR, creatinine, CK, rheumatoid factor, anti-CCP antibodies, and other autoantibodies. SLICC, SLEDAI, BILAG, DAS28, VAS, SLEDAI, BASDAI.<br>Cardiovascular risk factor analysis:<br>LDL, HDL, triglycerides, fasting blood glucose, smoking, systolic and diastolic blood pressure, BMI, patient-medication.<br>Functional questionnaires and quality of life assessment questionnaires (FFBh, HAQ, PDI, GAD-7, FACIT-Fatigue, EQ-5D, PHQ). <br>If necessary follow-up examinations in i.e. 6-12 monthly intervals in order to assess disease progression and/or effect of immunssuppressants and other therapies.
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