Acute Ischemic Stroke
Conditions
Keywords
Acute ischemic stroke, Intra-arterial hypothermic infusion, Neuroprotection, Endovascular Thrombectomy, Magnesium sulfate
Brief summary
The primary objective of this study is to estimate the safety of intra-arterial hypothermic magnesium sulfate infusion after endovascular thrombectomy in patients with acute ischemic stroke
Interventions
PROCEDUREIntra-arterial hypothermic magnesium sulfate infusion
According to patient's weight, magnesium sulfate (MgSO4) will be diluted to 330 ml 4°C saline solution (0.6μmol/kg/ml). During the thrombectomy procedure, a micro-catheter will be advanced until it reaches beyond the clot responsible for the ischemic symptoms, then cold 30 ml MgSO4 solution will be infused into the ischemic territory at 15 ml/min through the micro-catheter. After that, thrombectomy with a stent retriever will be performed to recanalize the occluded vessel as soon as possible. Immediately after successful thrombectomy, cold MgSO4 solution will be re-infused into the ischemic brain tissue through the catheter at a rate of 30 ml/min for 10 min.
PROCEDUREEndovascular thrombectomy
All patients that are eligible for endovascular thrombectomy will receive this surgery in aim to remove thrombus and restore reperfusion.
All patients that are eligible for Intravenous thrombolysis will receive 0.9mg/kg rt-PA in aim to remove thrombus and restore reperfusion
Sponsors
Capital Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age range of 18-80 years old (including critical value); 2. No gender restrictions; 3. The clinical diagnosis is acute ischemic stroke of the anterior circulation, and the site of acute occlusion of the responsible vessel is located in the intracranial segment of the internal carotid artery and the M1 or M2 segment of the middle cerebral artery; 4. The symptoms and signs are consistent with acute anterior circulation ischemic stroke, NIHSS≥6; 5. The time from onset to endovascular thrombectomy of acute ischemic stroke is within 24 hours; 6. Indications for endovascular thrombectomy of acute ischemic stroke: ① ASPECTS score ≥ 6 points, within 6 hours of onset; ② 6-16 hours after onset, meeting DEFUSE-3 criteria (infarct core volume \< 70 mL, mismatch rate ≥ 1.8 and mismatch volume \> 15 mL) or DAWN criteria (NIHSS ≥ 10 and infarct core volume \< 31 mL); Or NIHSS ≥ 20 and infarct volume 31-51 mL); ③ Within 16-24 hours of onset, meet DAWN criteria (NIHSS ≥ 10 points and infarct core volume \< 31mL); Or NIHSS ≥ 20 points and infarct volume 31-51 mL) 7. The mRS score before stroke is 0-1 points; 8. Written informed consent provided by the patients or their legal relatives.
Exclusion criteria
General
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mortality at 90 days | 90 days after intra-arterial hypothermic magnesium sulfate infusion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Grade 3-5 Treatment Emergent Adverse Event (TEAE) related to intervention occurring during treatment period | Within 72 hours after intra-arterial hypothermic magnesium sulfate infusion | TEAE includes but not limited to cardiovascular system response, abnormal electrocardiogram, water-electrolyte imbalance, core temperature decreasing, vascular spasm, shiver, infect, disturbance of consciousness. |
| All Treatment Emergent Adverse Event (TEAE) related to intervention occurring during treatment period | Within 72 hours after intra-arterial hypothermic magnesium sulfate infusion | — |
| All Treatment Emergent Adverse Event (TEAE) occurring during treatment period | Within 72 hours after intra-arterial hypothermic magnesium sulfate infusion | — |
| The proportion of symptomatic/asymptomatic intracranial hemorrhage within 24 h | Within 24 hours after intra-arterial hypothermic magnesium sulfate infusion | — |
Countries
China
Contacts
Primary ContactXunming Ji, MD, PhD
Outcome results
None listed