Ischemic Stroke Clinical Trial
— RESCUE-HYPOOfficial title:
A Prospective, Randomized-controlled Trial to Assess the Safety and Efficacy of Intravascular Hypothermia in Acute Ischemia Stroke Patients With Recanalization After Thrombectomy
Verified date | January 2023 |
Source | Beijing Tiantan Hospital |
Contact | Man Li |
Phone | 13141410249 |
lemmon_20[@]163.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary objective of this study is to determine the feasibility and safety of receiving intravascular hypothermia treatment for patients experiencing endovascular treatment after acute ischemic stroke(AIS) due to a large vessel occlusion.
Status | Not yet recruiting |
Enrollment | 30 |
Est. completion date | March 1, 2024 |
Est. primary completion date | March 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Aged 18-80 years; - Patients with symptoms consistent with an AIS; - Pre-stroke mRS score 0-1; - NIHSS score 6-30 at the time of randomization; - Computed Tomography Angiography (CTA) or Magnetic Resonance Angiography(MRA) proved occlusion of Internal Carotid Artery (ICA) terminal or M1 segment of Middle Cerebral Artery; - Imaging showed massive infarction: within 24h of onset and Alberta Stroke Program Early CT Score (ASPECTS) < 3, and large infarct core 70-100 ml (CT perfusion [ Relative Cerebral Blood Flow (rCBF) < 30%]); within 24h of onset and ASPCECTS score 3-5 (based on NCCT); ASPECTS > 5, within 6h-24h of onset,and large infarct core 70-100 ml (CTP [rCBF < 30%]); - Successful recanalization of occluded vessel (modified Thrombolysis in Cerebral Infarction (mTICI) scores 2b/3) after EVT; - Patients and/or their families agreed to enter the trial. Exclusion Criteria: - CT after reperfusion showed PH2 hemorrhagic transformation; - bilateral stroke or multiple intracranial occlusions; - known presence of Inferior Vena Cava (IVC) filter; - end-stage renal disease on hemodialysis; - known hemorrhagic diathesis, coagulation factor deficiency or platelet count < 5 × 109/L, International Normalized Ratio(INR) > 1.7; - known hypersensitivity to meperidine, buspirone, midazolam and other sedative and analgesic drugs; - pregnant women; - combined malignant tumors, sepsis, hypothyroidism; - unstable vital signs/dying state, requiring vasoactive drugs to maintain hemodynamic stability and in the incremental phase; - cardiac function grade 4/severe liver and kidney dysfunction; - has participated in other drugs or device clinical trials that may have an impact on the current study; - other reasons lead the investigator to believe that patients are not suitable to continue hypothermia treatment. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Liping Liu |
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* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of study group patients achieving target temperature < 34 ºC within 2 hour after recanalization. | Percentage of study group patients achieving target temperature < 34 ºC within 2 hour after recanalization. | 2 hour after thrombectomy | |
Primary | final infarct volume(FIV) | Infarct volume was assessed according to the non-contrast Computed Tomography (NCCT) 3-7 days after surgery, and if several NCCT examinations were performed within 3-7 days, the last CT was used. | three to seven days after endovascular therapy | |
Secondary | the rate of 90-day modified Rankin Scale (mRS)(0-2) | Compare the rate of 90-day mRS (0-2) between study group and control group | 90 days | |
Secondary | The rate of early neurological deterioration | increasing of National Institute of Health Stroke Scale(NIHSS) = 4 points 24 hours after recanalization | 24 hours | |
Secondary | The rate of mortality | The rate of mortality | 90 days | |
Secondary | Systematic Intracranial Hemorrhagr(sICH) | sICH with 24 ±3h post recanalization | 24 ±3hours |
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