Intra-Arterial Magnesium Therapy After Mechanical Thrombectomy in Acute Ischemic Stroke
ConditionAcute Ischemic Stroke
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age21-95
SponsorBaylor College of Medicine
About this trial
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 experiencing acute ischemic stroke. This trial is one of the first trials to look at IA administration of magnesium sulfate into at risk brain tissue in a selective and localized fashion.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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,
Disqualifiers
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;
Trial design
Design model
Sequential
Treatments tested in this trial
Magnesium sulfate
DrugFollowing MT and IA injection of MgSO4, patients will also receive a continuous infusion of 16g MgSO4 diluted in 240 ml of 0.9% normal saline, infusing at a rate of 10 ml per hour for 24 hours.
Treatment groups
30 Participants
are divided into 4 treatment groupsGroup A: 0.25g Magnesium SulfateExperimental treatment 1 intervention
Group B: 0.5g Magnesium SulfateExperimental treatment 1 intervention
Group C: 1.0g Magnesium SulfateExperimental treatment 1 intervention
Group D: 1.5g Magnesium SulfateExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Systemic MgSO4 Concentration
Time frame
6 hours post-MT, 24 hours post-MT2
Proportion of severe adverse events
severe adverse events including femoral artery dissection, local thrombosis, pseudoaneurysm, arteriovenous fistula, neurotoxicity and loss of reflexes due to magnesium, cardiovascular toxicity (arrythmias, severe bradycardia), respiratory depression
Time frame
48 hours post-MTSecondary outcomes
1
Proportion of patients with Modified Rankin Scale (mRS) 0 to 2
mRS is a measure of global disability. Total Scale range is 0-6, with lower values indicating better outcomes. mRS \</= 2 is considered functional independence based on modified Rankin score.
Time frame
90 days post-MT2
Modified Rankin Scales (mRS)
mRS is a measure of global disability. Total Scale range is 0-6, with lower values indicating better outcomes. 0\. No symptoms at all 1. No significant disability despite symptoms; able to carry out all usual duties and activities 2. Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance 3. Moderate disability; requiring some help, but able to walk without assistance 4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance 5. Severe disability; bedridden, incontinent and requiring constant nursing care and attention 6. Dead
Time frame
90 days post-MT3
Decrease in National Institutes of Health Stroke Scale (NIHSS)
NIHSS is a measure of neurologic deficit. Total Score range 0-42, with higher scores indicating greater severity. The 11 domains assessed are: 1a-c Level of consciousness 2. Best Gaze 3. Visual 4. Facial Palsy 5a. Motor left arm 5b. Motor right arm 6a. Motor left leg 6b. Motor right leg 7. Limb Ataxia 8. Sensory 9. Best Language 10. Dysarthria 11. Extinction and Inattention
Time frame
48 hours post-MT4
Proportion of symptomatic intracranial hemorrhage (sICH)
sICH defined as 4 or more increase in NIHSS caused by hemorrhage
Time frame
48 hours post-MTSponsors and contacts
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Source ClinicalTrials.gov