RecruitingPhase 2NCT06297863

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/b Trial in Patients Treated With Mechanical Thrombectomy

Sponsor

University of Milano Bicocca

Enrollment

118 participants

Start Date

Mar 1, 2025

Study Type

INTERVENTIONAL

Conditions

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°).

Eligibility

Min Age: 18 Years

Inclusion Criteria3

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

Exclusion Criteria11

Impaired consciousness, defined as NIHSS score of 2 or 3 of the item 1a (level of consciousness): not alert, requires repeated stimulation or unresponsive.
Vomiting upon stroke onset.
History of glaucoma.
History or imaging findings of intracranial hypertension of any aetiology
Major breath disorders, defined as follows:
oxygen saturation ≤92% in room air at admission
severe chronic obstructive pulmonary disease (COPD) treated with long-term oxygen therapy.
severe heart failure with NYHA class 3 or 4 (breathlessness during ordinary physical activity or at rest).
Severe obesity, defined as body mass index (BMI) > 35.
Patients participating in another interventional trial that would interfere with this study.
Female patients who are pregnant

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Interventions

PROCEDUREHEAD 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.