Head Down Tilt 15° to Increase Collateral Flow in Acute Ischemic Stroke: a Multicenter, Randomised, Proof of Concept, Phase 2a/b Trial in Patients Treated With Mechanical Thrombectomy
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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°).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Acute ischemic stroke due to left or right MCA occlusion of the M1 segment (excluding occlusion of the internal carotid artery terminus + M1)
• Decision to treat with mechanical thrombectomy (with or without intravenous thrombolysis)
• Informed consent obtained from patient or patient's next of kin, or emergency consent procedure
Locations
Other Locations
Italy
Ospedale Civile SS. Nicola e Filippo Avezzano Pronto Soccorso
NOT_YET_RECRUITING
Avezzano
Azienda Ospedaliero Universitaria Careggi
NOT_YET_RECRUITING
Florence
Azienda Ospedaliera Policlinico Universitario G. Martino
NOT_YET_RECRUITING
Messina
Fondazione IRCCS San Gerardo dei Tintori Monza
RECRUITING
Monza
Azienda Ospedaliero Universitaria Policlinico Umberto I
NOT_YET_RECRUITING
Roma
Ospedale Santa Maria della Misericordia
NOT_YET_RECRUITING
Udine
Contact Information
Primary
Simone Beretta, MD, PhD
simone.beretta@unimib.it
+390392333568
Backup
BiCRO (academic CRO)
bicro@unimib.it
Time Frame
Start Date:2025-03-01
Estimated Completion Date:2026-12-31
Participants
Target number of participants:118
Treatments
Experimental: HEAD DOWN TILT -10° to -15° (HDT15)
HDT15 will be applied in the intervention group in 2 different settings:~* 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~* 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.
No_intervention: USUAL POSITIONING
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.
Collaborators: Azienda Ospedaliero-Universitaria Careggi, Azienda Ospedaliero Universitaria, Santa Maria della Misericordia di Udine, Italy, Azienda Ospedaliera Universitaria Policlinico G. Martino, Fondazione IRCCS San Gerardo dei Tintori, Azienda Ospedaliero Universitaria Policlinico Umberto I, Roma, Università degli Studi dell'Aquila