Vasculitis, Anti-neutrophil cytoplasmatic antibody (ANCA), ANCA-associated vasculitis (AAV)
Conditions
Interventions
Group 1: Patients with autoimmune ANCA vasculitis.
Sponsors
Charité - Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: • BMI 20-35 • Severity of the clinical picture: active • Existing health insurance to clarify incidental findings
Exclusion criteria
Exclusion criteria: • Refusal to participate in the study • Legal incapacity or other circumstances that prevent patients from fully understanding the nature, significance, and implications of this study • MRI contraindications: metal implants in the body, contrast agent intolerance, pacemakers or defibrillators, claustrophobia • DVA contraindications: glaucoma, epilepsy • Pregnancy and/or active breastfeeding • Tinnitus (due to study-related MRI) • Allergy to the mydriatic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in reactive hyperemia index (RHI), measured using plethysmography on the index finger with EndoPat 2000, and reduction in flow-mediated vasodilation (FMD, µm) of the brachial artery, measured with UNEX EF 38G | — |
Secondary
| Measure | Time frame |
|---|---|
| - Reduced myocardial perfusion (ml/min/g), measured by MRI - Increased myocardial fibrosis (g), measured by MRI - Increase in end-diastolic volume (ml) and stroke volume of the left ventricle (ml), measured by MRI - Increased frequency of T cells (and corresponding subtypes) circulating in the blood, measured by isolating mononuclear cells from peripheral venous blood - Increase in the ratio of protein to creatinine (mg/mg) in spontaneous urine - Increase in skin autofluorescence (arbitrary units), measured with an AGE reader - Increase in body fat percentage (%), measured by bioimpedance analysis - Reduction in handgrip strength (kg), measured with a dynamometer - Increase in systolic and diastolic cBP (mmHg), measured using an oscillometric blood pressure monitor (Early Vue VS30, Philips) - Increase in systolic and diastolic 24-hour blood pressure (mmHg) in daytime and nighttime averages, measured using ABPMpro - Increase in PWV (m/s), measured with PulsePen - Increase in pulse wave velocity (m/s) at rest and during activity throughout the day, measured using ABPMpro - Reduction in walking distance (m) in the 6-minute walk test - Reduction in retinal nerve fiber layer (RNFL) thickness (µm), measured using optical coherence tomography (OCT) - Pathological changes in the peripheral retina, such as hemorrhages, exudates, or vascular anomalies, detected by funduscopy - Slowed dilation capacity of retinal vessels (%) when stimulated with flicker light, measured with Dynamic Vessel Analyzer (DVA) | — |
Countries
Germany
Contacts
Public ContactTill Schütte
Charité - Universitätsmedizin Berlin
Outcome results
None listed