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Endothelial Peripheral Arterial Tonometry (EndoPAT)

About

Status:
Ongoing
Principal investigator:
Country:
Germany
Study start:
2022-09-30
Completion (planned):
Not available
Last update:
2023-11-30

 

Research types:
Clinical research
Research areas:
Cardiovascular dysfunction
Interventions:
EndoPat 2000
Priv. Sector Partner:
Not available
Sponsors:

Project description

Endothelial Peripheral Arterial Tonometry (EndoPAT) studies, as part of the diagnostic platform within the National Clinical Study Group (NKSG).

The aim of the NKSG diagnostic platform is to identify diagnostic and prognostic markers of post-COVID syndrome (PCS) and ME/CFS in order to investigate treatment effects on imaging and vascular markers. The results of the diagnostic platform will improve the understanding of the disease and identify possible new treatment options. In addition to the therapeutic interventions in the respective NKSG clinical trials, patients part-taking in the NKSG hence receive state-of-the-art accompanying examinations. These include non-invasive analyses of the structure, function and blood flow of the brain via magnetic resonance imaging (MRI) and accompanying artial spin labeling (ASL), examinations of vascular endothelial function using EndoPAT and dynamic fundus vascular analysis (DVA), as well as measurement of retinal microcirculation using optical coherence tomography angiography (OCT-A). The examinations take place before and after treatment interventions and thus enable the effect of specific treatments to be analysed in-depth. In addition to study-specific clinical parameters, objective measurements of brain structure and function, vascular endothelial function and retinal microcirculation are available. These data enable an additional assessment of the effectiveness and mechanisms of action as well as a comparison of the different therapeutic approaches.

The diagnostic platform also takes current research results into account: PCS is associated with reduced cognitive performance and fatigue, is accompanied by structural and functional changes in the brain and can lead to disorders the retinal and choroidal microcirculation. The results of the NKSG diagnostic platform can therefore help to establish standards for data collection for MRI (incl. ASL), OCT-A, DVA and EndoPAT, which will facilitate the future diagnosis of PCS and ME/CFS patients in everyday clinical practice and which may be used as endpoints in clinical trials.

(Description adapted from project website: see link above)

Patient cohort

Post-COVID Syndrome (PCS) according to WHO as well as post-infectious ME/CFS according to Canadian Consensus Criteria (CCC), including post-COVID ME/CFS. Comparisson of sham/placebo vs treated patients or responders vs non-responders along clinical trials with healthy recovered COVID-19 patients and controls.

Patients enrolled: Not available

Age group: ≥ 18 years (Adults)

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