Acute Stroke
Conditions
Keywords
stroke, Magnesium, endovascular
Brief summary
Stroke is the second leading cause of death and the leading cause of adult disability worldwide. This investigation will address the safety and feasibility of directed, intra-arterial Magnesium measurement and therapy, through endovascular access, in acute stroke patients. The proposal represents the first study to directly quantify levels of a systemically administered neuroprotectant in the region of cerebral ischemia. It also establishes a novel endovascular platform for direct delivery of neuroprotective agents to ischemic cerebral tissue distal to an occlusive thrombus. This research seeks to improve patient care by establishing a novel delivery mechanism for the rescue of threatened brain parenchyma that can be administered rapidly following acute stroke. If successful, this selective distribution will allow delivery to at risk tissue in a rapid manner. Salvage of viable, but threatened, penumbral tissue could afford stroke patients an increased probability of favorable long term outcome. The investigators hypothesize that endovascular, intra-arterial, Magnesium administration will deliver high concentration of this neuroprotective agent to otherwise inaccessible cerebral territories, while limiting systemic concentrations. The proposed investigation will evaluate the safety and feasibility of this novel treatment technique
Interventions
DRUGMagnesium Sulfate
Intra-arterial
Sponsors
University of California, Los Angeles
University of Southern California
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 95 Years
Healthy volunteers
No
Inclusion criteria
1. Patient with acute cerebral ischemia due to ICA or MCA occlusion, 2. Patient's clinical attending physician plans mechanical embolectomy procedure as part of routine clinical care. 3. Age 21-95.
Exclusion criteria
1. Severe renal impairment with creatinine 3.0 or higher, 2. Myasthenia gravis, 3. Second or third degree heart block without a pacemaker in place, 4. Technical inability to navigate microcatheter to target clot, 5. Patient already enrolled in another experimental treatment trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Magnesium Concentration in Region of Cerebral Ischemia | Mg level: 1) Peripheral: Baseline and post-treatment (averaged); 2) Distal: after first pass of the clot retriever | Peripheral Magnesium Levels, meq/L will be obtained through the femoral sheath at the beginning (baseline) and end (post-treatment) of each case. These will be averaged to obtain a femoral Magnesium level. Magnesium levels distal to the occlusion will be measured at the first pass of the clot retrieving device. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Procedure Related Serious Adverse Event | intraprocedure, postoperative day 1, 1 month, 3 month | Periprocedural clinical, radiographic and laboratory data will be collected and analyzed to detect Mg related adverse events. Outcome will be assessed perioperatively and at 24 hours, 30 days (+/- 10 days) and 90 days (+/- 15 days) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Regional Intra-arterial Magnesium 0.75g Regional only 0.75 mg Magnesium Sulfate (50% Total Dose): 5 patients
Magnesium Sulfate: Intra-arterial | 4 |
| Regional Intra-arterial Magnesium 1.5g Regional Intra-arterial magnesium Sulfate Only 1.5g (100% TD): 5 patients
Magnesium Sulfate: Intra-arterial | 0 |
| Regional/ Distal (75/25%) Magnesium 1.5g Regional/ Distal(75% TD regional- 1.125g / 25% distal-0.375g): 5 patients
Magnesium Sulfate: Intra-arterial | 0 |
| Regional/ Distal (50/50%) Magnesium 1.5g Regional/ Distal (50% TD regional- 0.75g/ 50% distal-0.75g): 5 patients
Magnesium Sulfate: Intra-arterial | 0 |
| Total | 4 |
Baseline characteristics
| Characteristic | Regional Intra-arterial Magnesium 0.75g | Total |
|---|---|---|
| Age, Continuous | 68.25 years STANDARD_DEVIATION 13.25 | 68.25 years STANDARD_DEVIATION 13.25 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 4 Participants |
| Region of Enrollment United States | 4 Participants | 4 Participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 2 / 4 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 1 / 4 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Magnesium Concentration in Region of Cerebral Ischemia
Peripheral Magnesium Levels, meq/L will be obtained through the femoral sheath at the beginning (baseline) and end (post-treatment) of each case. These will be averaged to obtain a femoral Magnesium level. Magnesium levels distal to the occlusion will be measured at the first pass of the clot retrieving device.
Time frame: Mg level: 1) Peripheral: Baseline and post-treatment (averaged); 2) Distal: after first pass of the clot retriever
Population: Enrollment only occurred in the first arm (lowest dose) of the study as the arms were planned to enroll sequentially. The study was not stopped due to safety concerns
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Regional Intra-arterial Magnesium 0.75g | Magnesium Concentration in Region of Cerebral Ischemia | Distal Mg level | 1.475 meq/L | Standard Deviation 0.3403 |
| Regional Intra-arterial Magnesium 0.75g | Magnesium Concentration in Region of Cerebral Ischemia | Peripheral Mg level | 1.513 meq/L | Standard Deviation 0.2462 |
Secondary
Number of Participants With Procedure Related Serious Adverse Event
Periprocedural clinical, radiographic and laboratory data will be collected and analyzed to detect Mg related adverse events. Outcome will be assessed perioperatively and at 24 hours, 30 days (+/- 10 days) and 90 days (+/- 15 days)
Time frame: intraprocedure, postoperative day 1, 1 month, 3 month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Regional Intra-arterial Magnesium 0.75g | Number of Participants With Procedure Related Serious Adverse Event | 1 Participants |
| Regional Intra-arterial Magnesium 1.5g | Number of Participants With Procedure Related Serious Adverse Event | 0 Participants |
| Regional/ Distal (75/25%) Magnesium 1.5g | Number of Participants With Procedure Related Serious Adverse Event | 0 Participants |
| Regional/ Distal (50/50%) Magnesium 1.5g | Number of Participants With Procedure Related Serious Adverse Event | 0 Participants |