In the fight against cardiovascular (CV) diseases, scientists focus on the identification of individuals at a higher risk of developing CV events within 10 years, in order to concentrate preventive efforts on these subjects. Current traditional methods for risk prediction based on conventional risk factors have limitations and there is a need to identify more effective risk stratification algorithms. Endothelial dysfunction stands out as a reliable marker of CV risk because of its strong correlation with atherosclerosis and CV diseases (e.g. coronary disease, heart failure). Interestingly, recent studies claim that endothelial dysfunction is a common feature of clinical manifestations observed in COVID-19 patients. All of the drugs proposed as a potential therapeutic strategy to treat COVID-19 patients have been shown to improve endothelial function, including tocilizumab, colchicine, chloroquine/hydroxylchloroquine, azithromycin, and famotidine.

This proposal refers to a patented electrical impedance spectroscopy technology (ENDELIS) for non-invasive assessment of endothelial functionality in humans (EP 3245947 A1, 2017). This technology has been originally developed for sensing non-intrusively bubbles presence in the body of astronauts during decompression sickness, in the framework of a 10-year ESA project (EP3005942 Α1, 2016). It measures with exceptional sensitivity and accuracy bio-electrical signals that are correlated with biological functions. ENDELIS evaluates the functionality of brachial artery endothelium by means of 5 computed biomarkers, following the established FMD (Flow-Mediated Dilatation) medical protocol.

Until now, ultrasound assessment of FMD is clinically applied but it has major disadvantages: voluminous/expensive equipment, poor repeatability, low imaging resolution and mainly strong dependence on operator. ENDELIS, on the contrary, has much higher sensitivity and repeatability and is independent of the operator. Also, it is lightweight, cost-effective and easy to apply.

The development of ENDELIS is considerably beneficial to public health. Each year CV diseases cause 47% of all deaths in Europe and USA. Several CV incidents can be avoided or treated earlier and at the same time hospitalization can be eliminated reducing considerably the costs for the healthcare systems. Furthermore, ENDELIS use can be valuable during Covid-19 pandemia period, since assessment of endothelial functionality is critical for Covid-19 hospitalized patients. Therefore, quality and length of life for patients as well as sustainability of healthcare systems are improved. Furthermore, ENDELIS is portable enough to be applied in remoted areas. Acquired data can be transmitted via Bluetooth or Wi-Fi connection to mobile phone or computer network. Thus, telemedicine applications on different platforms (mobile phones, tablets, PC) can be used. Medical doctors can have access to collected data, assess endothelial functionality and consequently determine the CV risk of patients, providing in this way clinical health care at a distance. Moreover, ENDELIS may be employed for risk stratification in individuals without diagnosed CV disease but with typical clinical symptomatology and risk factors (history of diabetes, smoking, hypertension, dyslipidemia, obesity). Finally, it may be used to evaluate the response to particular therapeutic techniques (medication intensification and modification of risk factors).