G93.3
Conditions
Interventions
Group 1: The aim of this cross-sectional observational study is the pathophysiological characterization of vascular function and regulation, as well as organ perfusion, in patients with Chronic Fatigu
Sponsors
Charité - Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: only for ME/CFS patients: ME/CFS diagnosis (ICD-10 G93.3) and fullfilling Canadian Consensus Criteria or IOM criteria
Exclusion criteria
Exclusion criteria: - Participation as a subject in a therapeutic study - Acute infectious disease with existing antiviral or antibacterial therapy. - Chronic inflammatory disease with immunosuppressive therapy - Acute or chronic cardiovascular disease with existing oral or intravenous therapy - Malignant diseases. Patients who have been relapse-free for more than 5 years can be included in the study. - Atrophic (neuro)muscular diseases - Metabolic diseases with existing drug therapy. - Psychological comorbidity - No informed consent for study participation - Pregnancy - Bell Score>80
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This multicenter project aims to elucidate the role of vascular dysfunction and impaired perfusion in the pathophysiology of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). A shared patient cohort undergoes comprehensive clinical phenotyping, including detailed symptomatic, functional, and biochemical assessments. Vascular biomarker signatures with specificity for ME/CFS are derived from collected biosamples to enhance diagnostics, clinical stratification, and therapy monitoring. Pathophysiological alterations in skeletal muscle are investigated through indirect calorimetry, microdialysis, and muscle biopsy, focusing on energy metabolism and mitochondrial function. Retinal microcirculation is assessed using static and dynamic retinal vessel analysis and optical coherence tomography angiography (OCT-A). Cerebral vascular function and associated structural brain changes are evaluated via advanced magnetic resonance imaging (MRI) techniques. Cardiac investigations target myocardial perfusion and metabolism using specialized cardiac MRI protocols, including myocardial strain analysis and sodium spectroscopy. Collectively, the study integrates multimodal vascular and metabolic investigations to better understand disease mechanisms and identify potential diagnostic and therapeutic targets in ME/CFS. | — |
Secondary
| Measure | Time frame |
|---|---|
| comparison of cohorts | — |
Countries
Germany
Outcome results
None listed