Intra-Arterial Magnesium Therapy After Mechanical Thrombectomy in Acute Ischemic Stroke

May 12, 2025 updated by: Omar Tanweer, Baylor College of Medicine
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Radiology suite where the patient will undergo MT as per the standard of care. Participation in this study will never delay the timely provision of urgent MT to patients.

Additionally, as part of the study procedure, the patient will be assigned to Treatment Group 1,2, 3 or 4 based on the consecutive sampling scheme. The first 6 patients enrolled will be in group 1 and receive the lowest dose of MgSO4 as described below. If the analysis of this group deems this dosage to be safe, the following patients will be enrolled into group 2. The same scheme will be followed until all 4 groups are enrolled.

Patients in all groups will receive IA MgSO4 as follows (investigational):

Patients in each group will receive the specified dose of MgSO4 (listed below) diluted in 0.9% sodium chloride. The infusion of IA MgSO4 will be administered over 1-2 minutes.

Dose Escalation Schedule Group 1 0.25g IA MgSO4 Group 2 0.5g IA MgSO4 Group 3 1g IA MgSO4 Group 4 1.5g IA MgSO4

Given the minimal safety data on IA MgSO4, this dosage regimen was derived from previous IV MgSO4 studies and a singular IA MgSO4 study in a separate population to cautiously investigate the safety and tolerability for IA MgSO4.

Following MT and IA infusion, patients will receive a continuous infusion of IV MgSO4 for 24 hours. The maintenance infusion will contain 16g of MgSO4 diluted in 240 ml of 0.9% normal saline, infused at a rate of 10 ml per hour for 24 hours. Patients will follow the standard of care monitoring for post-MT patients with the addition of monitoring for magnesium toxicity.

All pre and post imaging is standard of care for this procedure, including follow up MRI (or CT if MRI contraindicated).

Following discharge from the hospital, all patients enrolled in the study protocol will be followed up in the clinic at 3 months to evaluate the patient's functional clinical outcome. If for any reason, the patient cannot come back for a follow-up visit, the PI/Co-PI's will contact the patient via phone/email to gather the required data. A minimum of mRS and NIHSS should be gathered for follow-up data.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patient with acute cerebral ischemia due to ICA or MCA occlusion
  2. Major neurologic deficits: 6≤NIHSS≤20,
  3. Premorbid mRS 0 or 1, or 2
  4. Patient's clinical attending physician plans MT procedure as part of routine clinical care,
  5. undergo MT with a TICI 2a or better recanalization,
  6. Signed informed consent.

Exclusion Criteria:

  1. Positive pregnancy test;
  2. those undergoing MT with a TICI <2a revascularization;
  3. tandem occlusion of the cervical common or internal carotid artery; and
  4. 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;
  5. Second or third-degree heart block without a pacemaker in place,
  6. Technical inability to navigate micro-catheter to target clot,
  7. Patient already enrolled in another experimental treatment trial. Exclusion criteria 1-3 are all contraindications to magnesium therapy,
  8. mRS>2 caused by a history of prior stroke,
  9. 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;
  10. Unsuitable for this clinical study assessed by researcher. Subjects will not be excluded if they received IV t-PA as standard of care.
  11. patient is on neuromuscular blocking agents including depolarizing (succinylcholine) and nondepolarizing subtypes (rocuronium, vecuronium, etc);
  12. patient is taking any form of CNS depressant including barbiturates, narcotics, outside the setting of anesthesia or ICU sedation
  13. patients taking digoxin or other cardiac glycoside

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 0.25g Magnesium Sulfate
0.25g of magnesium sulfate (MgSO4) will be diluted in 0.9% sodium chloride for intra-arterial (IA) administration via the guide catheter already in place in the intracranial internal carotid artery (ICA) on the affected side for MT. The infusion will be administered over 1-2 minutes.
Drug: Magnesium sulfate
Following 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.
Other Names:
  • MA 135 magnesium sulfate heptahydrate
Experimental: 0.5g Magnesium Sulfate
0.5g of magnesium sulfate (MgSO4) will be diluted in 0.9% sodium chloride for intra-arterial (IA) administration via the guide catheter already in place in the intracranial ICA on the affected side for MT. The infusion will be administered over 1-2 minutes.
Drug: Magnesium sulfate
Following 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.
Other Names:
  • MA 135 magnesium sulfate heptahydrate
Experimental: 1.0g Magnesium Sulfate
1.0g of magnesium sulfate (MgSO4) will be diluted in 0.9% sodium chloride for intra-arterial (IA) administration via the guide catheter already in place in the intracranial ICA on the affected side for MT. The infusion will be administered over 1-2 minutes.
Drug: Magnesium sulfate
Following 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.
Other Names:
  • MA 135 magnesium sulfate heptahydrate
Experimental: 1.5g Magnesium Sulfate
1.5g of magnesium sulfate (MgSO4) will be diluted in 0.9% sodium chloride for intra-arterial (IA) administration via the guide catheter already in place in the intracranial ICA on the affected side for MT. The infusion will be administered over 1-2 minutes.
Drug: Magnesium sulfate
Following 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.
Other Names:
  • MA 135 magnesium sulfate heptahydrate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systemic MgSO4 Concentration
Time Frame: 6 hours post-MT, 24 hours post-MT
6 hours post-MT, 24 hours post-MT
Proportion of severe adverse events
Time Frame: 48 hours post-MT
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
48 hours post-MT

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Rankin Scales (mRS)
Time Frame: 90 days post-MT

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
90 days post-MT
Decrease in National Institutes of Health Stroke Scale (NIHSS)
Time Frame: 48 hours post-MT

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
48 hours post-MT
Proportion of symptomatic intracranial hemorrhage (sICH)
Time Frame: 48 hours post-MT
sICH defined as 4 or more increase in NIHSS caused by hemorrhage
48 hours post-MT
Proportion of hemorrhagic transformation
Time Frame: 48 hours post-MT
48 hours post-MT
All causes of death after treatment
Time Frame: 48 hours post-MT, 90 days post-MT
48 hours post-MT, 90 days post-MT
Proportion of patients with Modified Rankin Scale (mRS) 0 to 2
Time Frame: 90 days post-MT
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.
90 days post-MT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor College of Medicine

Investigators

  • Principal Investigator: Omar Tanweer, MD, Baylor College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

December 2, 2024

First Submitted That Met QC Criteria

May 1, 2025

First Posted (Actual)

May 4, 2025

Study Record Updates

Last Update Posted (Actual)

May 14, 2025

Last Update Submitted That Met QC Criteria

May 12, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-50731

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Ischemic Stroke

Clinical Trials on Magnesium sulfate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe