NCT07096687Recruiting
Targeted Temperature Management in Acute Ischemic Stroke
Targeted Temperature Management for Neuroprotection in Acute Ischemic Stroke: A Randomized Controlled Pilot Trial
Source: ClinicalTrials.gov · Last updated 17 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goal of this interventional trial is to evaluate whether the CB240\_Aurora medical device is effective for targeted temperature management in adult patients with acute ischemic stroke. The main questions it aims to answer are: Is the CB240\_Aurora effective in maintaining normothermia in patients with acute ischemic stroke? Does the medical device improve clinical and radiological outcomes? Is the medical device well tolerated by patients? Researchers will compare an interventional arm, in which the CB240\_Aurora measures and treats body temperature to maintain normothermia, with a control arm, in which the CB240\_Aurora only measures but does not treat body temperature. Participants will wear the medical device for 72 consecutive hours in the Stroke Unit. Outcome assessments will be performed at 72 hours, 7 days, and 3 months.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 22 (estimated)
- First submitted
- 24 Jul 2025
- Start date
- 11 Sept 2025
- Primary completion date
- Sept 2026
- Lead sponsor
- Azienda Usl di Bologna
- Diseases
- Stroke
- NCT number
- NCT07096687
What you commit to
- Study type: Interventional
- Planned participants: 22
- From 11 Sept 2025 to the primary completion date, Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Stroke involving multiple vascular territories;
- Presence of intracerebral hemorrhage;
- Moderate-to-severe or severe pre-stroke disability defined as mRS \>3;
- Presence of a cardiac pacemaker or any other conditions contraindicating brain MRI.
Other
- Pregnancy;
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS Istituto delle Scienze Neurologiche di Bologna - AUSL of Bologna Coordinator of this site? Confirm its status | Bologna | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.