Targeted temperature management for acute ischemic stroke

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 interventional trial compares active targeted temperature management using the CB240_Aurora device to a control arm in which the device only monitors temperature in adults with anterior circulation ischemic stroke. The CB240_Aurora targets cerebral temperature via vascular heat exchange in the neck and is worn continuously for 72 hours in the Stroke Unit. Outcomes include maintenance of normothermia and clinical and radiological measures recorded at 72 hours, 7 days, and 3 months. Enrollment requires imaging-confirmed MCA occlusion and NIHSS criteria, with exclusions for hemorrhage, multiple-territory stroke, pregnancy, significant pre-stroke disability, and MRI contraindications.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age \>18 years;
* Both sexes;
* Diagnosis of acute ischemic stroke confirmed by clinical evaluation by a neurologist and neuroimaging (CT or brain MRI);
* Acute ischemic stroke with symptom onset within 48 hours;
* Anterior circulation stroke with evidence on neuroimaging (CT angiography) of occlusion of the middle cerebral artery in segments M1, M2, or M3;
* NIHSS score between 6 and 25;
* First clinical stroke;
* Axillary temperature ≥36°C and \<37°C;
* Informed consent obtained for study participation.

Exclusion Criteria:

* Stroke involving multiple vascular territories;
* Presence of intracerebral hemorrhage;
* Pregnancy;
* Moderate-to-severe or severe pre-stroke disability defined as mRS \>3;
* Presence of a cardiac pacemaker or any other conditions contraindicating brain MRI.

Where it's running

• IRCCS Istituto delle Scienze Neurologiche di Bologna - AUSL of Bologna
  Bologna, Bologna, Italy Recruiting

Study contacts

• Principal investigator: Andrea Zini — IRCCS Istituto delle Scienze Neurologiche di Bologna - AUSL of Bologna
• Study coordinator: Andrea Zini
• Email: a.zini@ausl.bologna.it
• Phone: +390516478810

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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.