Intra-arterial Hypothermic Magnesium Sulfate Infusion in Combination with Endovascular Thrombectomy in Acute Ischemic Stroke

NCT06760195 | Not Yet Recruiting Early Phase 1

• 1 other identifier: Hypo-Mag
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Ischemic Stroke

Keywords

Acute ischemic stroke; Intra-arterial hypothermic infusion; Neuroprotection; Endovascular Thrombectomy; Magnesium sulfate

Outcome Measures

Primary Outcomes (1)

• Mortality at 90 days

  90 days after intra-arterial hypothermic magnesium sulfate infusion

Secondary Outcomes (4)

• 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

• 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

Study Arms (1)

Intra-arterial hypothermic magnesium sulfate infusion

EXPERIMENTAL

Patients will receive intra-arterial hypothermic magnesium sulfate infusion after endovascular thrombectomy.

Procedure: Intra-arterial hypothermic magnesium sulfate infusion; Procedure: Endovascular thrombectomy; Drug: Intravenous thrombolysis

Interventions

Intra-arterial hypothermic magnesium sulfate infusion PROCEDURE

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.

Intra-arterial hypothermic magnesium sulfate infusion

Endovascular thrombectomy PROCEDURE

All patients that are eligible for endovascular thrombectomy will receive this surgery in aim to remove thrombus and restore reperfusion.

Intra-arterial hypothermic magnesium sulfate infusion

Intravenous thrombolysis DRUG

All patients that are eligible for Intravenous thrombolysis will receive 0.9mg/kg rt-PA in aim to remove thrombus and restore reperfusion

Intra-arterial hypothermic magnesium sulfate infusion

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age range of 18-80 years old (including critical value);
• No gender restrictions;
• 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;
• The symptoms and signs are consistent with acute anterior circulation ischemic stroke, NIHSS≥6;
• The time from onset to endovascular thrombectomy of acute ischemic stroke is within 24 hours;
• 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)
• The mRS score before stroke is 0-1 points;
• Written informed consent provided by the patients or their legal relatives.

You may not qualify if:

• 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;
• 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;
• CTA/MRA/DSA shows excessive vessel curvature, which may hinder the delivery of interventional instruments;

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Xunming Ji, MD, PhD

CONTACT

010-83198952; jixm@ccmu.edu.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 3, 2025
• First Posted: January 6, 2025
• Study Start: January 10, 2025
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: January 7, 2025

Record last verified: 2024-12

Locations

CN (1)