Head Down Tilt 15° to Increase Collateral Flow in Acute Ischemic Stroke

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°).

Conditions

• Acute Ischemic Stroke

Interventions

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. Application 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. The 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.

Sponsors & Collaborators

• Fondazione IRCCS San Gerardo dei Tintori

  collaborator OTHER

• Azienda Ospedaliero-Universitaria Careggi

  collaborator OTHER

• Azienda Ospedaliera Universitaria Policlinico "G. Martino"

  collaborator OTHER

• Azienda Ospedaliero Universitaria, Santa Maria della Misericordia di Udine, Italy

  collaborator OTHER

• Università degli Studi dell'Aquila

  collaborator OTHER

• Azienda Ospedaliero Universitaria Policlinico Umberto I, Roma

  collaborator UNKNOWN

• University of Milano Bicocca

  lead OTHER

Principal Investigators

• Simone Beretta, MD, PhD · University of Milano Bicocca

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-03-01

Primary Completion

2026-09-30

Completion

2026-12-31

Countries

• Italy

Study Locations