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| Name | Class |
|---|---|
| The Affiliated Hospital of Xuzhou Medical University | OTHER |
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The primary objective of this study is to estimate the safety and effectiveness of selective intra-arterial hypothermic magnesium sulfate infusion after endovascular thrombectomy in patients with acute ischemic stroke
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Selective intra-arterial hypothermic magnesium sulfate infusion of low volume | Experimental | Endovascular thrombectomy combination with selective intra-arterial hypothermic magnesium sulfate infusion (350 ml). |
|
| Selective intra-arterial hypothermic magnesium sulfate infusion of moderate volume | Experimental | Endovascular thrombectomy combination with selective intra-arterial hypothermic magnesium sulfate infusion (500 ml). |
|
| Selective intra-arterial hypothermic magnesium sulfate infusion of high volumn | Experimental | Endovascular thrombectomy combination with selective intra-arterial hypothermic magnesium sulfate infusion (650 ml). |
|
| Control | Sham Comparator | Endovascular thrombectomy alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endovascular thrombectomy combination with selective intra-arterial hypothermic magnesium sulfate infusion (350 ml). | Procedure | According to patient's weight, magnesium sulfate (MgSO4) will be diluted to 350 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 50 ml MgSO4 solution will be infused into the ischemic territory at 10 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality at 90 days | 90 days after intra-arterial hypothermic magnesium sulfate infusion | |
| Effectiveness evaluation indicators: | Percentage of subjects with 90 days of functional independence (defined as mRS 0-2) (%) Evaluation time: 90 d (±14 d) after surgery | 90 days after intra-arterial hypothermic magnesium sulfate infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Grade 3-5 Treatment Emergent Adverse Event (TEAE) related to intervention occurring during treatment period | TEAE includes but not limited to cardiovascular system response, abnormal electrocardiogram, water-electrolyte imbalance, core temperature decreasing, vascular spasm, shiver, infect, disturbance of consciousness. | Within 72 hours after intra-arterial hypothermic magnesium sulfate infusion |
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Inclusion Criteria:
Exclusion Criteria:
General exclusion criteria:
Clinical manifestations suggest the presence of intracranial cerebral parenchymal hemorrhage or subarachnoid hemorrhage (even if imaging results are normal);
During a stroke, accompanied by epilepsy, an accurate NIHSS score cannot be obtained;
Accompanied by coma or mental disorders, it may interfere with the assessment of neurological function;
History of allergy to iodinated contrast agents or history of anaphylactic shock;
Baseline blood glucose<50mg/dL (2.78mmol) or>400mg/dL (22.20mmol);
*Acceptable fingertip blood glucose results
Baseline platelet count<50 × 10^9/L;
Recently (i.e. within 30 days prior to inclusion in the study), there has been a history of significant gastrointestinal or other clinically significant bleeding; Active bleeding, abnormal coagulation factors, or bleeding tendency (taking anticoagulant drugs with INR ≥ 3 or PT ≥ 3 × ULN; if the researcher believes that the subject has no coagulation dysfunction, there is no need to wait for coagulation test results to determine whether to enroll);
During a stroke, there may be fever or active infections that require systemic treatment (such as active pulmonary tuberculosis);
History of chronic heart failure with NYHA criteria>1; Uncontrolled hypertension (systolic blood pressure>180mmHg or diastolic blood pressure>105mmHg after standardized treatment), hypotension (systolic blood pressure ≤ 100mmHg after standardized treatment), unstable angina, myocardial infarction, or bypass or stent surgery within 6 months;
Accompanied by pulmonary diseases such as chronic obstructive pulmonary disease, tuberculosis, pneumonia, pneumothorax, atelectasis, pulmonary fibrosis, bronchopulmonary dysplasia, pleural effusion, acute respiratory distress syndrome, irregular breathing, etc;
Severe liver and kidney dysfunction, including but not limited to: cirrhosis, hepatic encephalopathy, ascites, renal failure or uremia (Ccr<25ml/min), hepatorenal syndrome, etc;
Pregnant or lactating women;
Patients with acute stroke within 48 hours after percutaneous cardiovascular and cerebrovascular intervention and major surgery;
Currently participating in interventional clinical trials and using research drugs or medical devices;
Participants may not be able to complete this study due to other reasons or may not be considered eligible for inclusion by the researchers;
Image exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Hospital of Xuzhou Medical University | Xuzhou | Jiangsu | 221000 | China |
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This study was divided into two parts. The first part was a dose escalation study (non-randomized) using a "3+3" design. The second part was a randomized, parallel, open-label, endpoint-blinded study conducted at the maximum tolerated dose (MTD)
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| Endovascular thrombectomy combination with selective intra-arterial hypothermic magnesium sulfate infusion (500 ml). | Procedure | According to patient's weight, magnesium sulfate (MgSO4) will be diluted to 500 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 50 ml MgSO4 solution will be infused into the ischemic territory at 10 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. Then pause for 5 min, followed by another 5 min of infusion at the original rate. |
|
| Endovascular thrombectomy combination with selective intra-arterial hypothermic magnesium sulfate infusion (650 ml). | Procedure | According to patient's weight, magnesium sulfate (MgSO4) will be diluted to 650 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 50 ml MgSO4 solution will be infused into the ischemic territory at 10 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. Then pause for 5 min, followed by intermittent infusion at the original rate for another 5 min twice. The interval between two times is also 5 min. |
|
| Endovascular thrombectomy | Procedure | Endovascular thrombectomy |
|
| 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 hours | Within 24 hours after intra-arterial hypothermic magnesium sulfate infusion |
| No reflow rate | No reflow rate, defined as the percentage of subjects with a decrease in CBV or CBF by more than 15% compared to the contralateral side at 24 hours after treatment (%) | 24 hours (±6 hours) after surgery |
| Cerebrospinal fluid parameters | The levels of Mg²⁺, glutamate, NFL, MMP-9, inflammatory factors, as well as the metabolomics/proteomics of cerebrospinal fluid, are used to verify the central nervous system protection mechanism | 24 hours-7 day |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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