Acute StrokePhase 1/2NCT01502761
Intra-arterial Magnesium Administration for Acute Stroke
A Phase 1/2 study testing Magnesium Sulfate in people with Acute Stroke, run by University of Southern California at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 95 years
- Conditions the study is for
- Acute Stroke
- What is being tested?
- Magnesium Sulfate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2012to May 2016
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with acute cerebral ischemia due to ICA or MCA occlusion,
- Patient's clinical attending physician plans mechanical embolectomy procedure as part of routine clinical care.
- Age 21-95.
Who cannot join
- Severe renal impairment with creatinine 3.0 or higher,
- Myasthenia gravis,
- Second or third degree heart block without a pacemaker in place,
- Technical inability to navigate microcatheter to target clot,
- Patient already enrolled in another experimental treatment trial. Exclusion criteria 1-3 are all contraindications to magnesium therapy.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University California Los Angeles: Ronald Reagan and Santa Monica Hospitals
Los Angeles, California, 900094
University of Southern California University and LA County Hospitals
Los Angeles, California, 90033
About this study
Official title: Intra-arterial Magnesium Therapy: A Novel Platorm for Neuroprotectant Delivery in Acute Stroke
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
- Conditions
- Acute Stroke
- Being tested
- Magnesium Sulfate
- Keywords
- stroke, Magnesium, endovascular
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium SulfateDrug
Intra-arterial
| Study group | Role | What they receive |
|---|---|---|
| Regional Intra-arterial Magnesium 0.75g | Experimental | Regional Intra-arterial magnesium only 0.75 mg Magnesium Sulfate (50% Total Dose): 5 patients Receives: Drug: Magnesium Sulfate |
| Regional Intra-arterial magnesium 1.5g | Experimental | Regional Intra-arterial magnesium Sulfate Only 1.5g (100% TD): 5 patients Receives: Drug: Magnesium Sulfate |
| Regional/ Distal (75/25%) Magnesium 1.5g | Experimental | Regional/ Distal intra-arterial magnesium (75% TD regional- 1.125g / 25% distal-0.375g): 5 patients Receives: Drug: Magnesium Sulfate |
| Regional/ Distal (50/50%) Magnesium 1.5g | Experimental | Regional/ Distal intra-arterial magnesium (50% TD regional- 0.75g/ 50% distal-0.75g): 5 patients Receives: Drug: Magnesium Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Mg level: 1) Peripheral: Baseline and post-treatment (averaged); 2) Distal: after first pass of the clot retriever
Secondary outcomes (1)
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)
Measured: intraprocedure, postoperative day 1, 1 month, 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2012 (estimated)
- Study startMar 2012
- Primary completionMay 2016
- Study completionMay 2016
Why it stopped: No safety issues. Low enrollment secondary to negative stroke studies 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute StrokeStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles
- Responsible party
- Principal investigator, William Mack, University of Southern California
- Investigators
- William J Mack, MD, Principal investigator, University of Southern CaliforniaJeffrey Saver, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01502761
- Sponsor's protocol ID
- HS-11-00339
- Status last verified
- Jul 2017
- First submitted
- 22 Dec 2011
- Last updated
- 28 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-arterial Magnesium Therapy: A Novel Platorm for Neuroprotectant Delivery in Acute Stroke
- ClinicalTrials.gov ID
- NCT01502761
- Acronym / sponsor ID
- HS-11-00339
- Conditions
- Acute Stroke
- Keywords
- stroke, Magnesium, endovascular
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No safety issues. Low enrollment secondary to negative stroke studies 2013
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- University of California, Los Angeles
- Study start
- Mar 2012
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 2 Jan 2012 (estimated)
- Results
- Posted 28 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Regional Intra-arterial Magnesium 0.75g | Experimental | Drug: Magnesium SulfateRegional Intra-arterial magnesium only 0.75 mg Magnesium Sulfate (50% Total Dose): 5 patients |
| Regional Intra-arterial magnesium 1.5g | Experimental | Drug: Magnesium SulfateRegional Intra-arterial magnesium Sulfate Only 1.5g (100% TD): 5 patients |
| Regional/ Distal (75/25%) Magnesium 1.5g | Experimental | Drug: Magnesium SulfateRegional/ Distal intra-arterial magnesium (75% TD regional- 1.125g / 25% distal-0.375g): 5 patients |
| Regional/ Distal (50/50%) Magnesium 1.5g | Experimental | Drug: Magnesium SulfateRegional/ Distal intra-arterial magnesium (50% TD regional- 0.75g/ 50% distal-0.75g): 5 patients |
Who may qualify
- Ages
- 21 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient with acute cerebral ischemia due to ICA or MCA occlusion,
- Patient's clinical attending physician plans mechanical embolectomy procedure as part of routine clinical care.
- Age 21-95.
Key exclusion criteria (5 listed)
- Severe renal impairment with creatinine 3.0 or higher,
- Myasthenia gravis,
- Second or third degree heart block without a pacemaker in place,
- Technical inability to navigate microcatheter to target clot,
- Patient already enrolled in another experimental treatment trial. Exclusion criteria 1-3 are all contraindications to magnesium therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium SulfateIntra-arterial | Drug | Regional Intra-arterial Magnesium 0.75g, Regional Intra-arterial magnesium 1.5g, Regional/ Distal (50/50%) Magnesium 1.5g, Regional/ Distal (75/25%) Magnesium 1.5g |
Primary outcome
Magnesium Concentration in Region of Cerebral Ischemia
Time frame: 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.
1 secondary outcome
Number of Participants With Procedure Related Serious Adverse Event
Time frame: intraprocedure, postoperative day 1, 1 month, 3 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Acute Stroke
Recruiting
Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
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Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage, Stroke
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A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
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Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
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Not yet recruitingPhase 3
INTRA-ARTERIAL MeVO TREATMENT (IMP-ACT) Within the ACT-GLOBAL Adaptive Platform Trial-NCT06352632
Stroke, Acute Ischemic, Medium Vessel Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William J Mack, MD principal investigator
University of Southern California
Jeffrey Saver, MD principal investigator
University of California, Los Angeles
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Magnesium Sulfate in people with Acute Stroke, run by University of Southern California at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Magnesium Concentration in Region of Cerebral Ischemia (time frame: Mg level: 1) Peripheral: Baseline and post-treatment (averaged); 2) Distal: after first pass of the clot retriever). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2017.