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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00031470

Enrollment

570

Registered

2023-03-17

Start date

2016-12-15

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

Group 1: Patients (18-80 years of age) with systemic inflammatory rheumatic diseases (connective tissue diseases, vasculitides, arthritides) and chronic pain syndromes (fibromyalgia syndrome, somatiza

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Aortic vascular stiffness measured using carotid-femoral pulse wave velocity (cfPWFV).	—

Secondary

Measure	Time frame
Assessment of the vascular situation by carotid ultrasonography, nailfold capillaroscopy (NVC), and retinal vessel analysis (RVA). Retrospective analysis of the following parameters and scores of disease activity: C3c, C4, dsDNA, ANA, CRP, ESR, creatinine, CK, rheumatoid factor, anti-CCP antibodies, and other autoantibodies. SLICC, SLEDAI, BILAG, DAS28, VAS, SLEDAI, BASDAI. Cardiovascular risk factor analysis: LDL, HDL, triglycerides, fasting blood glucose, smoking, systolic and diastolic blood pressure, BMI, patient-medication. Functional questionnaires and quality of life assessment questionnaires (FFBh, HAQ, PDI, GAD-7, FACIT-Fatigue, EQ-5D, PHQ). 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.	—

Measure

Time frame

Assessment of the vascular situation by carotid ultrasonography, nailfold capillaroscopy (NVC), and retinal vessel analysis (RVA). Retrospective analysis of the following parameters and scores of disease activity: C3c, C4, dsDNA, ANA, CRP, ESR, creatinine, CK, rheumatoid factor, anti-CCP antibodies, and other autoantibodies. SLICC, SLEDAI, BILAG, DAS28, VAS, SLEDAI, BASDAI. Cardiovascular risk factor analysis: LDL, HDL, triglycerides, fasting blood glucose, smoking, systolic and diastolic blood pressure, BMI, patient-medication. Functional questionnaires and quality of life assessment questionnaires (FFBh, HAQ, PDI, GAD-7, FACIT-Fatigue, EQ-5D, PHQ). 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.

—

Countries

Germany

Contacts

Public ContactKonstantinos Triantafyllias

Rheumazentrum Rheinland-Pfalz GmbH

Dr.Konstantinos.Triantafyllias@rheumazentrum-rlp.de+49 671-93 22 51

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026