Azienda Ospedaliero-Universitaria Careggi

The heart is a unique organ that performs an incessant work to pump blood throughout the body. For this massive effort, it requires a very high supply of energy. Mitochondria are small components of the cells responsible for the production of energy. To produce energy, mitochondria from cardiac cells can use fuel of different origins (fats, glucose, proteins, etc). In normal circumstances, cardiac mitochondria use preferentially fats since they are more efficient in terms of quantify of energy produced. Recent data from our consortium has demonstrated that if the cardiac mitochondria switch the primary source of fuel (from fats to glucose), this results in a poor performance of the organ, which cannot supply the whole body with enough blood. This is known as heart failure. In experimental models of heart failure, we have demonstrated that a high fat diet is able to reverse the metabolic switch and make the cardiac cells mitochondria use again fats as the primary substrate to produce energy. This translates into a recovery of heart failure. In the present project, we plan to bring this concept to the human setting and perform a pilot clinical study where patients with heart failure are put in a dietary program consisting of high fat diet. The effect of this nutritional approach will be evaluated by state-of-the-art non-invasive imaging technology.

The DOWN-SUITE study is multicenter, randomised, controlled, open-label clinical trial with blinded outcome assessment comparing collateral status in patients with acute ischemic stroke treated with an in-hospital application of head down tilt -10° to -15° (HDT15) versus usual positioning (0° to +30°) before endovascular mechanical thrombectomy.
This study will involve adult patients who are eligible for mechanical thrombectomy and who have acute ischemic stroke due to left or right middle cerebral artery occlusion (M1 segment).
The investigators hypothesise that HDT15, applied in acute ischemic stroke patients with a large vessel occlusion, will improve collateral circulation, prolong the survival of the ischemic penumbra and improve the clinical benefit from mechanical thrombectomy compared with standard of care (usual positioning 0° to +30°).

The aim of the clinical investigation is to evaluate the feasibility, in terms of efficacy and safety, of a prosthetic system, the Regrasp 1 system, based on intraneural stimulation via TIME- 4H electrodes, as an aid device for restoring hand function in tetraplegic patients.