Back to resultsReperfusion With Hypothermia in Acute Ischemic Stroke (RESCUE-HYPO)
Primary Purpose
Ischemic Stroke, Revascularization, Endovascular Treatment
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Thermogard XP3
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Stroke focused on measuring Ischemic Stroke, Revascularization, Endovascular Treatment, Reperfusion Injury
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Study group
Control group
Arm Description
The subjects will be considered to be enrolled in the study group of the trial when all inclusion and exclusion criteria have been met, the informed consent form has been signed, and randomization to the study group of the trial to allow endovascular therapy with the Thermogard XP3 Intravascular Temperature Management (IVTM) System after recanalization.
The subjects will be considered to be enrolled in the control group of the trial when all inclusion and exclusion criteria have been met, the informed consent form has been signed, and randomization to the control group of the trial.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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
The rate of early neurological deterioration
increasing of National Institute of Health Stroke Scale(NIHSS) ≥ 4 points 24 hours after recanalization
The rate of mortality
The rate of mortality
Systematic Intracranial Hemorrhagr(sICH)
sICH with 24 ±3h post recanalization
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05676957
Brief Title
Reperfusion With Hypothermia in Acute Ischemic Stroke
Acronym
RESCUE-HYPO
Official Title
A Prospective, Randomized-controlled Trial to Assess the Safety and Efficacy of Intravascular Hypothermia in Acute Ischemia Stroke Patients With Recanalization After Thrombectomy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 1, 2023 (Anticipated)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Liping Liu
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
Detailed Description
Hypothermia has been confirmed and widely applied in the treatment of coma patients after resuscitation from cardiac arrest, but its effect on the prognosis of patients with AIS is still controversial. Previous basic research has confirmed that hypothermia can significantly reduce the infarct volume and improve the survival rate and behavioral defects of mice by protecting ischemic brain tissue and improving reperfusion injury through a variety of ways. Therefore, we hypothesized that hypothermia can improve the prognosis of patients with AIS after reperfusion by improving reperfusion injury. This is a phase II clinical trial to to verify the efficacy and safety of endovascular hypothermia in these patients,This study enrolled patients with massive cerebral infarction after endovascular treatment recanalization, patients are divided into study group and control group. The study group received endovascular hypothermia for 12 hours following endovascular treatment and recanalization, and the control group received only usual medical treatment following endovascular treatment and recanalization. We will preliminarily explore the mechanism of endovascular hypothermia in successful reperfusion of large vessel occlusion AIS, and to provide reference for the design of future clinical trials.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke, Revascularization, Endovascular Treatment, Reperfusion Injury
Keywords
Ischemic Stroke, Revascularization, Endovascular Treatment, Reperfusion Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Experimental
Arm Description
The subjects will be considered to be enrolled in the study group of the trial when all inclusion and exclusion criteria have been met, the informed consent form has been signed, and randomization to the study group of the trial to allow endovascular therapy with the Thermogard XP3 Intravascular Temperature Management (IVTM) System after recanalization.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The subjects will be considered to be enrolled in the control group of the trial when all inclusion and exclusion criteria have been met, the informed consent form has been signed, and randomization to the control group of the trial.
Intervention Type
Device
Intervention Name(s)
Thermogard XP3
Other Intervention Name(s)
intravascular hypothermia treatment
Intervention Description
Patients received endovascular hypothermia for 12 hours following endovascular treatment and recanalization.
Primary Outcome Measure Information:
Title
Percentage of study group patients achieving target temperature < 34 ºC within 2 hour after recanalization.
Description
Percentage of study group patients achieving target temperature < 34 ºC within 2 hour after recanalization.
Time Frame
2 hour after thrombectomy
Title
final infarct volume（FIV）
Description
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.
Time Frame
three to seven days after endovascular therapy
Secondary Outcome Measure Information:
Title
the rate of 90-day modified Rankin Scale (mRS)(0-2)
Description
Compare the rate of 90-day mRS (0-2) between study group and control group
Time Frame
90 days
Title
The rate of early neurological deterioration
Description
increasing of National Institute of Health Stroke Scale(NIHSS) ≥ 4 points 24 hours after recanalization
Time Frame
24 hours
Title
The rate of mortality
Description
The rate of mortality
Time Frame
90 days
Title
Systematic Intracranial Hemorrhagr(sICH)
Description
sICH with 24 ±3h post recanalization
Time Frame
24 ±3hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Man Li
Phone
13141410249
Email
lemmon_20@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liping Liu
Organizational Affiliation
Beijing Tiantan Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Reperfusion With Hypothermia in Acute Ischemic Stroke
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