STIMULUS project consortium develops new non-invasive, convenient, low-cost and easy-to-use imaging technology that can measure new digital biomarkers from microcirculation for early detection of cardiovascular diseases. The novel technology will enable earlier detection of heart failure and chronic kidney disease, which will substantially decrease cardiovascular events in the European population.
Development of new integrated solution and clinical trials
For both heart failure and chronic kidney disease patients, it is important to diagnose microvascular dysfunction and monitor the deterioration of microvascular function in early phases of the disease progress. Our proposed technology HEMI-speckle system is an integrated solution of two existing prototypes, namely, the multi-spectral optical sensory system and the speckle plethysmography (SPG) system. To understand the diagnostic value of these technologies for both HF and CKD populations, two clinical trials will be executed. At the same time, the new integrated solution will be developed. Adjustment of the existing individual technologies can be made prior to conduct of the validation trial to guarantee a proper conduct of the trial in a patient population in a clinical setting. Lessons learnt from these clinical trials can be used a) for the development of the integrated HEMI-speckle system, b) to identify new digital biomarkers from the individual and integrated technology, c) to analyse the sensitivity and specificity of the two technologies for each population separately, and d) to prove the validity of the technologies for the early assessment of microvascular function in the target population. A third clinical trial will run in a later phase, when the HEMI-speckle prototype is ready. In this trial, the new technology will be verified on healthy volunteers and hypertensives, after the validation of the underlying technologies on a relevant patient population has been done. The additional new digital biomarkers obtained from the unique combination of the two individual technologies can be explored in this phase.
Health technology assessment
One of the key roles of Technology Assessment is to provide prospective knowledge about the possible or probable consequences of new and emerging technologies. In the process, intended and non-intended impacts of the technology application are identified. Anticipating the spectrum of possible consequences of technology, at an early stage, helps to make good use of the potential of progress and to be able to minimize risks or even to avoid them.
