Acute StrokeNCT01502748
Endovascular Magnesium Sampling in Acute Stroke
A study testing endovascular sampling in people with Acute Stroke, run by University of Southern California at 2 sites in United States.
Trial summary
This investigation will address the safety and feasibility of distal, intra-arterial sampling through endovascular access, in acute stroke patients. Levels of Magnesium will be measured in the region of infarct in patients who had been treated with intravenous Magnesium therapy following an acute stroke. Read more about this study
- Who is it for?
- Ages 40 to 95 years
- Conditions the study is for
- Acute Stroke
- What is being tested?
- endovascular sampling
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2012to Feb 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 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 already enrolled in the NIH FAST-MAG clinical trial,
- Patient's clinical attending physician plans mechanical embolectomy procedure as part of routine clinical care.
- Age 40-95 inclusive (age criteria for FAST-MAG Trial).
Who cannot join
- Technical inability to navigate microcatheter to target clot.
- Patient or surrogate unavailable for consent
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: Magnesium Therapy: a Novel Platform for Neuroprotectant Sampling in Acute Stroke
This investigation will address the safety and feasibility of distal, intra-arterial sampling through endovascular access, in acute stroke patients. Levels of Magnesium will be measured in the region of infarct in patients who had been treated with intravenous Magnesium therapy following an acute stroke. This study attempts to address whether the traditional intravenous means of neuroprotectant administration achieves adequate concentration of the therapeutic agent in the area of diseased tissue.
- Conditions
- Acute Stroke
- Being tested
- endovascular sampling
- 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.
endovascular samplingOther
Paired sampling from the distal arterial(endovascular catheter) and peripheral venous (femoral sheath) locations: withdrawal of 3ml of blood from vasculature distal to the occlusive thrombus
| Study group | Role | What they receive |
|---|---|---|
| Endovascular Sampling | Experimental | Paired sampling from the distal arterial(endovascular catheter) and peripheral venous (femoral sheath) locations in acute stroke patients undergoing endovascular recanalization who received intravenous Magnesium Sulfate as a part of the FAST-MAG study Receives: Other: endovascular sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnesium concentration
The primary endpoint is the relative concentration of Mg in the core cerebral ischemic zone, compared to systemic therapeutic Mg levels, as a measure of delivery efficacy of systemic administration.
Measured: intra-procedure (at time of first pass of retrieval device)
Secondary outcomes (2)
Sampling feasibility
sampling feasibility will be determined by the proportion of cases in which a cerebral circulation Mg level was successfully assayed
Measured: intra-procedural (at time of first pass of retrieval device)
Safety
safety will be assessed by intraoperative adverse events, postoperative neurologic examination including NIH stroke scale, and postoperative brain imaging.
Measured: post-operative day 1
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 completionFeb 2013
- Study completionFeb 2013
Why it stopped: FAST-Mag study finished
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute StrokeStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 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
- NCT01502748
- Sponsor's protocol ID
- HS-11-00311
- Other IDs
- 12BGIA8700001
- Status last verified
- Jul 2017
- First submitted
- 25 Dec 2011
- Last updated
- 1 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnesium Therapy: a Novel Platform for Neuroprotectant Sampling in Acute Stroke
- ClinicalTrials.gov ID
- NCT01502748
- Acronym / sponsor ID
- HS-11-00311
- Conditions
- Acute Stroke
- Keywords
- stroke, Magnesium, Endovascular
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: FAST-Mag study finished
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- University of California, Los Angeles
- Study start
- Mar 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 2 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This investigation will address the safety and feasibility of distal, intra-arterial sampling through endovascular access, in acute stroke patients. Levels of Magnesium will be measured in the region of infarct in patients who had been treated with intravenous Magnesium therapy following an acute stroke. This study attempts to address whether the traditional intravenous means of neuroprotectant administration achieves adequate concentration of the therapeutic agent in the area of diseased tissue.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endovascular Sampling | Experimental | Other: endovascular samplingPaired sampling from the distal arterial(endovascular catheter) and peripheral venous (femoral sheath) locations in acute stroke patients undergoing endovascular recanalization who received intravenous Magnesium Sulfate as a part of the FAST-MAG study |
Who may qualify
- Ages
- 40 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient with acute cerebral ischemia due to ICA or MCA occlusion,
- Patient already enrolled in the NIH FAST-MAG clinical trial,
- Patient's clinical attending physician plans mechanical embolectomy procedure as part of routine clinical care.
- Age 40-95 inclusive (age criteria for FAST-MAG Trial).
Key exclusion criteria (2 listed)
- Technical inability to navigate microcatheter to target clot.
- Patient or surrogate unavailable for consent
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 |
|---|---|---|
| endovascular samplingPaired sampling from the distal arterial(endovascular catheter) and peripheral venous (femoral sheath) locations: withdrawal of 3ml of blood from vasculature distal to the occlusive thrombus | Other | Endovascular Sampling |
Primary outcome
Magnesium concentration
Time frame: intra-procedure (at time of first pass of retrieval device)
The primary endpoint is the relative concentration of Mg in the core cerebral ischemic zone, compared to systemic therapeutic Mg levels, as a measure of delivery efficacy of systemic administration.
2 secondary outcomes
Sampling feasibility
Time frame: intra-procedural (at time of first pass of retrieval device)
Safety
Time frame: post-operative day 1
Results and safety
The study was stopped early (reason given: FAST-Mag study finished). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
- Individual participant dataSharing planned: No
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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 study testing endovascular sampling 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 4 inclusion and 2 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 1 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.
Are results available for this study?
The study was stopped early (reason given: FAST-Mag study finished). Results are not available in the source record.
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 (time frame: intra-procedure (at time of first pass of retrieval device)). 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 1 Aug 2017.