Head down tilt to improve blood flow in stroke patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Fondazione IRCCS San Gerardo dei Tintori Monza
  Monza, Italy Recruiting
• 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
• 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
• Email: simone.beretta@unimib.it
• Phone: +390392333568

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.