Intra-arterial Selective Hypothermic Magnesium Sulfate Infusion in Combination With Endovascular … (NCT07163299) | Clinical Trial Compass
By InvitationPhase 1/2
Intra-arterial Selective Hypothermic Magnesium Sulfate Infusion in Combination With Endovascular Thrombectomy in Acute Ischemic Stroke
China42 participantsStarted 2025-09-15
Plain-language summary
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
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mortality at 90 days
Timeframe: 90 days after intra-arterial hypothermic magnesium sulfate infusion
2
Effectiveness evaluation indicators:
Timeframe: 90 days after intra-arterial hypothermic magnesium sulfate infusion
. 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;
. 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);