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Study on the Efficacy and Safety of Intracranial Focal Hypothermia Combined with Endovascular Recanalization in Circulating Acute Aortic Occlusive Cerebral Infarction Before Circulation:A Prospective, Open-label, Endpoint-Blind, Randomized Controlled Study (CHILL-ART Study)

Study on the Efficacy and Safety of Intracranial Focal Hypothermia Combined with Endovascular Recanalization in Circulating Acute Aortic Occlusive Cerebral Infarction Before Circulation:A Prospective, Open-label, Endpoint-Blind, Randomized Controlled Study (CHILL-ART Study)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500100551
Enrollment
Unknown
Registered
2025-04-10
Start date
2025-01-23
Completion date
Unknown
Last updated
2025-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute ischemic stroke

Interventions

Hypothermia group:Hypothermic saline therapy
Normothermia group:Normothermic saline therapy

Sponsors

Guangdong Second Provincial General Hospital (Guangdong Provincial Emergency Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1.Age >=18 and =6 points before randomization. 6.According to the judgment of the clinician, the operation path is reasonable, and the operation and operation related instruments can reach the disease smoothly. 7.Patients or their guardians can understand the purpose of the trial, voluntarily participate and sign a written informed consent, and are capable of receiving clinical follow-up. 8. Prior to randomization, CTA, MRA, or DSA confirmed the presence of anterior circulatory large vessel occlusion (internal carotid artery or M1segment). 9.The symptoms are aggravated by recurrent cerebral infarction in the same drainage basin and/or the pathogenesis is caused by decreased blood perfusion.

Exclusion criteria

Exclusion criteria: 1.Pre stroke mRS>1 score. 2.There are acute infarcts in both cerebral hemispheres and/or anterior and posterior circulation. 3.NIHSS1.5, PT> 1 minute above the upper limit of normal, or heparin-related thrombocytopenia). 6.Patients with heart function of grade 1 or above, or with a clear history of acute or chronic heart dysfunction, are at greater risk of acute heart failure or fluid perfusion intolerance as determined by clinicians. 7. Severe heart, liver, kidney disease. 8.With malignant diseases such as malignant tumors, the expected survival time is less than 3 months. 9.Participating in other clinical trials, in the investigational phase or in the follow-up phase.

Design outcomes

Primary

MeasureTime frame
Modified Rankin Scale (mRS) score at 90 days;

Secondary

MeasureTime frame
National Institutes of Health Stroke Scale (NIHSS score);Symptomatic intracranial hemorrhage rate;Mortality rate;Cerebral infarct volume;Recanalization success rate;

Countries

China

Contacts

Public ContactZhixin Huang

Guangdong Second Provincial General Hospital (Guangdong Provincial Emergency Hospital)

huangjamie@126.com+86 18898546655

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026