[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100538978":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":37,"responsibleParty":114,"collaborators":116,"id":130,"slug":131,"hasResults":132,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":132,"sex":138,"minAge":139,"maxAge":18,"enrollmentInfo":140,"targetDuration":18,"studyType":143,"phases":144,"briefSummary":146,"conditions":147,"keywords":149,"overallStatus":80,"whyStopped":18,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":162},{"fullName":5,"class":6},"University of Milano Bicocca","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"HEAD DOWN TILT -10° to -15° (HDT15)","EXPERIMENTAL","HDT15 will be applied in the intervention group in 2 different settings:\n\n* in the Emergency Room, by tilting the stretcher to lower the head by -10° to -15° relative to the body of the patient; the degree of tilting will be checked using a dedicated digital inclinometer or a mobile phone app\n* in the Angiography Suite, by tilting the angiography table to lower the head by -10° to -15° relative to the body of the patient, depending on the actual technology of the angiography system of each clinical site; the degree of tilting will be automatically checked using the angiography system HDT15 will start as soon as possible following randomisation in the Emergency Room (i.e. after vascular neuroimaging), and will be maintained during the transfer to the Angiography Suite, as well as during the entire thrombectomy procedure. HDT15 will end after the completion of mechanical thrombectomy.",[13],"Procedure: HEAD DOWN TILT -10° to -15°",{"label":15,"type":16,"description":17,"interventionNames":18},"USUAL POSITIONING","NO_INTERVENTION","Patients randomised in the control group will be maintained in the usual position during the emergency room phase (0° to +30°) and on the angiography table (0°), according to standard practice. Mechanical thrombectomy will be performed as per usual care.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"PROCEDURE","HEAD DOWN TILT -10° to -15°","Head down tilt -10° to -15° (HDT15) is a positional therapy consisting of tilting the patient with the head -10° to -15° degrees below the rest of the body.\n\nApplication of HDT15 will not delay usual care. The standard in-hospital patient pathway, including transfer from neuroimaging room to the angiography suite and the required procedural steps of MT, will allow sufficient time for the application of HDT15. HDT15 duration is expected to be at least 30 minutes (estimated time 30 to 90 minutes), from start to the assessment of the primary efficacy endpoint.\n\nThe actual degree of HDT15 will be a range between -10° to -15°, depending on the angiographic system of each clinical site, but it will be maintained at -15° during the Emergency Room phase which is expected to account for \\>50% of the total application time.",[9],[26],{"name":27,"affiliation":5,"role":28},"Simone Beretta, MD, PhD","PRINCIPAL_INVESTIGATOR",[30,34],{"name":27,"role":31,"phone":32,"phoneExt":18,"email":33},"CONTACT","+390392333568","simone.beretta@unimib.it",{"name":35,"role":31,"phone":18,"phoneExt":18,"email":36},"BiCRO (academic CRO)","bicro@unimib.it",[38,54,66,78,90,102],{"facility":39,"status":40,"city":41,"state":18,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Ospedale Civile SS. Nicola e Filippo Avezzano Pronto Soccorso","NOT_YET_RECRUITING","Avezzano","67051","Italy","IT",{"type":46,"coordinates":47},"Point",[48,49],13.42641,42.02896,{"lat":49,"lon":48},[52],{"name":53,"role":28,"phone":18,"phoneExt":18,"email":18},"Simona Sacco, MD, PhD",{"facility":55,"status":40,"city":56,"state":18,"zip":57,"country":43,"countryCode":44,"cosmosGeoPoint":58,"geoPoint":62,"contacts":63},"Azienda Ospedaliero Universitaria Careggi","Florence","50134",{"type":46,"coordinates":59},[60,61],11.24626,43.77925,{"lat":61,"lon":60},[64],{"name":65,"role":28,"phone":18,"phoneExt":18,"email":18},"Enrico Fainardi, MD, PhD",{"facility":67,"status":40,"city":68,"state":18,"zip":69,"country":43,"countryCode":44,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"Azienda Ospedaliera Policlinico Universitario \"G. Martino\"","Messina","98124",{"type":46,"coordinates":71},[72,73],15.55256,38.19394,{"lat":73,"lon":72},[76],{"name":77,"role":28,"phone":18,"phoneExt":18,"email":18},"Sergio Vinci, MD, PhD",{"facility":79,"status":80,"city":81,"state":18,"zip":82,"country":43,"countryCode":44,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"Fondazione IRCCS San Gerardo dei Tintori Monza","RECRUITING","Monza","20900",{"type":46,"coordinates":84},[85,86],9.27246,45.58005,{"lat":86,"lon":85},[89],{"name":27,"role":28,"phone":18,"phoneExt":18,"email":18},{"facility":91,"status":40,"city":92,"state":18,"zip":93,"country":43,"countryCode":44,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"Azienda Ospedaliero Universitaria Policlinico Umberto I","Roma","00161",{"type":46,"coordinates":95},[96,97],11.10642,44.99364,{"lat":97,"lon":96},[100],{"name":101,"role":28,"phone":18,"phoneExt":18,"email":18},"Danilo Toni, MD, PhD",{"facility":103,"status":40,"city":104,"state":18,"zip":105,"country":43,"countryCode":44,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"Ospedale Santa Maria della Misericordia","Udine","33100",{"type":46,"coordinates":107},[108,109],13.23715,46.0693,{"lat":109,"lon":108},[112],{"name":113,"role":28,"phone":18,"phoneExt":18,"email":18},"Francesco Janes, MD, PhD",{"type":115,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[117,119,121,123,125,127],{"name":118,"class":6},"Fondazione IRCCS San Gerardo dei Tintori",{"name":120,"class":6},"Azienda Ospedaliero-Universitaria Careggi",{"name":122,"class":6},"Azienda Ospedaliera Universitaria Policlinico \"G. Martino\"",{"name":124,"class":6},"Azienda Ospedaliero Universitaria, Santa Maria della Misericordia di Udine, Italy",{"name":126,"class":6},"Università degli Studi dell'Aquila",{"name":128,"class":129},"Azienda Ospedaliero Universitaria Policlinico Umberto I, Roma","UNKNOWN","100538978","phase-2-head-down-tilt-15-to-increase-collateral-flow-in-acute-ischemic-stroke-100538978",false,"NCT06297863","Head Down Tilt 15° to Increase Collateral Flow in Acute Ischemic Stroke","Head Down Tilt 15° to Increase Collateral Flow in Acute Ischemic Stroke: a Multicenter, Randomised, Proof of Concept, Phase 2a\u002Fb Trial in Patients Treated With Mechanical Thrombectomy","DOWN-SUITE","Inclusion Criteria:\n\n* Acute ischemic stroke due to left or right MCA occlusion of the M1 segment (excluding occlusion of the internal carotid artery terminus + M1)\n* Decision to treat with mechanical thrombectomy (with or without intravenous thrombolysis)\n* Informed consent obtained from patient or patient's next of kin, or emergency consent procedure\n\nExclusion Criteria:\n\n* Impaired consciousness, defined as NIHSS score of 2 or 3 of the item 1a (level of consciousness): not alert, requires repeated stimulation or unresponsive.\n* Vomiting upon stroke onset.\n* History of glaucoma.\n* History or imaging findings of intracranial hypertension of any aetiology\n* Major breath disorders, defined as follows:\n\n  * oxygen saturation ≤92% in room air at admission\n  * severe chronic obstructive pulmonary disease (COPD) treated with long-term oxygen therapy.\n  * severe heart failure with NYHA class 3 or 4 (breathlessness during ordinary physical activity or at rest).\n* Severe obesity, defined as body mass index (BMI) \\> 35.\n* Patients participating in another interventional trial that would interfere with this study.\n* Female patients who are pregnant","ALL","18 Years",{"count":141,"type":142},118,"ESTIMATED","INTERVENTIONAL",[145],"PHASE2","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.\n\nThis 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).\n\nThe 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°).",[148],"Acute Ischemic Stroke",[150,151,152],"Collaterals","Cerebral hemodynamics","Head down positioning","2026-04-29",{"date":155,"type":156},"2026-05-06","ACTUAL",{"date":158,"type":156},"2025-03-01",{"date":160,"type":142},"2026-12-31",{"name":5,"class":6},6]