Head down tilt to improve blood flow in stroke patients

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

This study is testing if tilting stroke patients' heads down can improve blood flow to their brains and help them recover better before they receive treatment.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 118 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Milano Bicocca (Academic / other)
• Locations: 6 sites (Avezzano and 5 other locations)
• Trial ID: NCT06297863 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of a head down tilt position (15°) on collateral blood flow in patients experiencing acute ischemic stroke due to middle cerebral artery occlusion. It is a multicenter, randomized, controlled trial comparing this positional therapy against standard positioning before mechanical thrombectomy. The hypothesis is that the head down tilt will enhance collateral circulation, potentially preserving brain tissue and improving outcomes. The study aims to gather data on the efficacy of this approach in increasing the salvageable brain tissue and extending the treatment window for reperfusion therapies.

Who should consider this trial

Good fit: Ideal candidates are adults with acute ischemic stroke caused by left or right middle cerebral artery occlusion who are eligible for mechanical thrombectomy.

Not a fit: Patients with impaired consciousness, severe respiratory issues, or other significant comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved clinical outcomes for stroke patients undergoing mechanical thrombectomy.

How similar studies have performed: Previous studies have shown promising results with similar positional therapies, but this specific approach is novel in the context of acute ischemic stroke.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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

Where this trial is running

Avezzano and 5 other locations

• Ospedale Civile SS. Nicola e Filippo Avezzano Pronto Soccorso — Avezzano, Italy (Not_yet_recruiting)
• Azienda Ospedaliero Universitaria Careggi — Florence, Italy (Not_yet_recruiting)
• Azienda Ospedaliera Policlinico Universitario "G. Martino" — Messina, Italy (Not_yet_recruiting)
• Fondazione IRCCS San Gerardo dei Tintori Monza — Monza, Italy (Recruiting)
• Azienda Ospedaliero Universitaria Policlinico Umberto I — Roma, Italy (Not_yet_recruiting)
• Ospedale Santa Maria della Misericordia — Udine, Italy (Not_yet_recruiting)

Study contacts

• Principal investigator: Simone Beretta, MD, PhD — University of Milano Bicocca
• Study coordinator: Simone Beretta, MD, PhD

Conditions Acute Ischemic Stroke; Collaterals; Cerebral hemodynamics; Head down positioning