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Not yet taking people in ChinaEarly phase 1

Testing a cooled magnesium infusion with clot removal for acute stroke

Tests cooled magnesium sulfate delivered into the artery in adults with acute ischemic stroke.

Key facts

Who runs it
Capital Medical University
Where
Beijing, ChinaSee the site
Trial code
Registry title
Intra-arterial Hypothermic Magnesium Sulfate Infusion in Combination with Endovascular Thrombectomy in Acute Ischemic Stroke
Status
Not yet recruiting
Phase
Early phase 1
People taking part
6 people, planned
Started
10 Jan 2025
Planned end
30 Jun 2025
Type of study
Interventional
Treatments tested
  • Intra-arterial hypothermic magnesium sulfate infusion
  • Endovascular thrombectomy
  • Intravenous thrombolysis
Record updated
7 January 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 18-80 with an acute stroke caused by a blocked artery at the front of the brain, who are having a clot-removal procedure (endovascular thrombectomy).

Age
18 to 80 years old.
Sex
All sexes can join.
Disease stage
Acute ischemic stroke of the anterior circulation, with a blockage in the internal carotid artery or the M1 or M2 segment of the middle cerebral artery. NIHSS score of 6 or more. Thrombectomy within 24 hours of onset. Brain scan criteria depend on the time since onset.

Main reasons for not taking part

  • Bleeding in the brain, or signs that suggest it
  • Pregnant or breastfeeding women
  • Severe liver or kidney problems, or serious heart or lung disease
  • Allergy to iodinated contrast agent, or recent major bleeding
  • Brain imaging showing tumor, bleeding, moyamoya disease or blockages in several vessel areas

The registry criteria, word for word

Show all 32 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Currently participating in interventional clinical trials and using research drugs or medical devices
  • 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
  • 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
  • Patients with acute stroke within 48 hours after percutaneous cardiovascular and cerebrovascular intervention and major surgery
  • CTA/MRA/DSA confirms moyamoya disease or moyamoya syndrome
  • CT/MRI confirms the presence of intracranial hemorrhage
  • 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)
  • General exclusion criteria:
  • Pregnant or lactating women
  • 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:
  • CTA/MRA/DSA shows excessive vessel curvature, which may hinder the delivery of interventional instruments
  • Suspected cerebral vasculitis based on medical history and CTA/MRA/DSA
  • Suspected aortic dissection based on medical history and CTA/MRA/DSA
  • CTA/MRA/DSA confirmed multi vessel regional occlusion (such as bilateral anterior circulation or anterior/posterior circulation, extracranial carotid artery with intracranial tandem lesions), or clinical evidence of bilateral infarction or multi regional infarction
  • CT/MRI confirms significant effect of midline shift
  • CT/MRI confirms the presence of intracranial tumors (excluding small meningiomas)

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 80 years old?

Where in China

  • Xuanwu Hospital, Capital Medical UniversityBeijing, ChinaContact: Yang Zhang, MDNo longer taking part

About the trial

What the trial wants to find out

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

The group in the trial

  • Intra-arterial hypothermic magnesium sulfate infusionTreatment being tested

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

    Treatment: Intra-arterial hypothermic magnesium sulfate infusion, Endovascular thrombectomy, and Intravenous thrombolysis

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Intra-arterial Hypothermic Magnesium Sulfate Infusion in Combination with Endovascular Thrombectomy in Acute Ischemic Stroke: a Safety Study
Plain-language title
Testing a cooled magnesium infusion with clot removal for acute strokeGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06760195, who can take part
Record updated
7 January 2025