Ricerca Progetti nazionali, regionali, internazionaliNAZIONALIPRIN 2022Head down tilt 15° to increase collateral flow

Head down tilt 15° to increase collateral flow in acute ischemic stroke: a translational, multi-center, randomized, proof of concept phase 2a trial in patients treated with mechanical thrombectomy (DOWN-SUITE)

Investigating and implementing a collateral therapeutic is a major objective in stroke research. The primary aim of increasing cerebral collateral flow in acute ischemic stroke is to preserve potentially salvageable penumbral tissue and expand the time window for recanalization therapies. Previous experimental studies in rodents from the University of Milano Bicocca indicate that the head down tilt 15° (HDT15) position, applied after arterial occlusion, increases cerebral collateral flow and reduces infarct size and neurological disability, if reperfusion is achieved. HDT15 is simple, low cost, feasible and represents the ideal "collateral therapeutic" to be applied as an emergency treatment in patients with acute ischemic stroke, prior to recanalization therapies. The DOWN-SUITE study is a translational, multi-center, randomized controlled, open label, proof-of-concept phase 2a clinical trial with blinded outcome assessment, comparing collateral status in patients with acute ischemic stroke due to middle cerebral artery (MCA) occlusion (M1 segment) treated with in-hospital application of HDT15 (-15°) positioning versus usual positioning (+30°/0°) before mechanical thrombectomy. In-hospital application of HDT15 will start immediately after cerebral vascular diagnostic imaging and will last until the completion of endovascular mechanical thrombectomy. Duration of HDT15 application (approximately 30-60 minutes) is expected to be long enough to detect significant changes in cerebral hemodynamics. For the patient’s perspective, HDT15 application will be in a controlled and protected setting (the emergency room and neurointerventional suite) and will not interfere with the thrombectomy procedure. The study population has been selected to have the best expected response to HDT15, since occlusion of the M1 segment of the MCA is usually associated to some recruitment of collaterals, which could be further increased by HDT15. The DOWN-SUITE study will provide for the first time the translation of HDT15 efficacy on cerebral hemodynamics from animal stroke models to human stroke. The DOWN-SUITE study holds the potential of establishing HDT15 as the first evidence-based collateral therapeutic for acute ischemic stroke. The results of the DOWN-SUITE study will pave the way for larger, multi-national, randomized controlled clinical trials of HDT15 in patients with suspected acute stroke in the pre-hospital setting, to be applied as emergency treatment before recanalization therapies. The ultimate goal of the DOWN-SUITE project will be the implementation of HDT15 as practice-changing, standard-of-care emergency treatment of hyperacute stroke, easily implementable at a global level, with a revolutionary effect in the stroke care system and a positive impact on stroke outcome, with reduced costs of hospitalization, long-term care and disability.

 

Data di avvio 18 Ottobre 2023

Data di completamento 18 Ottobre 2025

Total cost  € 61822,00

 

Progetto 2022LNL3H3 finanziato all’interno del Bando PRIN 2022 di cui al Decreto Direttoriale n. 104 del 02/02/2022 nell’ambito del Piano Nazionale di Ripresa e Resilienza, Missione 4 – Componente 2. Dalla Ricerca all’Impresa - Investimento 1.1 Fondo per il Programma Nazionale della Ricerca (PNR) e Progetti di Ricerca di Rilevante Interesse Nazionale (PRIN), finanziato dall’Unione europea – NextGenerationEU – CUP B53D23018770006