Status:
NOT_YET_RECRUITING
Intra-Arterial Magnesium Therapy After Mechanical Thrombectomy in Acute Ischemic Stroke
Lead Sponsor:
Baylor College of Medicine
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
21-95 years
Phase:
PHASE1
Brief Summary
The goal of this Phase I unblinded, dose-escalation trial is to evaluate the safety and tolerability of intra-arterial magnesium sulfate injection after mechanical thrombectomy in patients experiencin...
Detailed Description
Patients meeting inclusion and exclusion criteria will undergo a baseline neurologic assessment and will be enrolled following informed consent. The patient will then be taken to the Interventional Ra...
Eligibility Criteria
Inclusion
- Patient with acute cerebral ischemia due to ICA or MCA occlusion
- Major neurologic deficits: 6≤NIHSS≤20,
- Premorbid mRS 0 or 1, or 2
- Patient's clinical attending physician plans MT procedure as part of routine clinical care,
- undergo MT with a TICI 2a or better recanalization,
- Signed informed consent.
Exclusion
- Positive pregnancy test;
- those undergoing MT with a TICI \<2a revascularization;
- tandem occlusion of the cervical common or internal carotid artery; and
- subjects on therapeutic anticoagulation, as it is a relative contraindication to MT, and could be a confounding variable predisposing to intracranial hemorrhage including coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia \<80000/mm3;
- Second or third-degree heart block without a pacemaker in place,
- Technical inability to navigate micro-catheter to target clot,
- Patient already enrolled in another experimental treatment trial. Exclusion criteria 1-3 are all contraindications to magnesium therapy,
- mRS\>2 caused by a history of prior stroke,
- Severe hepatic dysfunction, severe renal dysfunction (\<30 mL/min), increase in ALT or AST (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis;
- Unsuitable for this clinical study assessed by researcher. Subjects will not be excluded if they received IV t-PA as standard of care.
- patient is on neuromuscular blocking agents including depolarizing (succinylcholine) and nondepolarizing subtypes (rocuronium, vecuronium, etc);
- patient is taking any form of CNS depressant including barbiturates, narcotics, outside the setting of anesthesia or ICU sedation
- patients taking digoxin or other cardiac glycoside
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06956521
Start Date
June 1 2025
End Date
July 1 2026
Last Update
May 14 2025
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