Study on vascular stiffness using carotid-femoral pulse wave velocity (cfPWV) in patients with systemic inflammatory rheumatic diseases and chronic pain syndromes.
- Conditions
- Patients with systemic inflammatory rheumatic diseases (collagenoses, vasculitides, arthritides) and chronic pain syndromes (fibromyalgia syndrome, somatization disorders).M00-M25M30-M36M05-M14M45-M49M60-M63M79F45I77Arthropathies
- 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
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.
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
Name Time Method Aortic vascular stiffness measured using carotid-femoral pulse wave velocity (cfPWFV).
- Secondary Outcome Measures
Name Time Method 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.