Acute Ischemic StrokeEarly Phase 1Hypo-MagNCT06760195
Intra-arterial Hypothermic Magnesium Sulfate Infusion in Combination with Endovascular Thrombectomy in Acute Ischemic Stroke
A Early Phase 1 study testing Intra-arterial hypothermic magnesium sulfate infusion, Endovascular thrombectomy and Intravenous thrombolysis in people with Acute Ischemic Stroke, run by Capital Medical University at 1 site in China.
Trial summary
The primary objective of this study is to estimate the safety of intra-arterial hypothermic magnesium sulfate infusion after endovascular thrombectomy in patients with acute ischemic stroke Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Intra-arterial hypothermic magnesium sulfate infusion, Endovascular thrombectomy and Intravenous thrombolysis
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2025to 30 Jun 2025
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age range of 18-80 years old (including critical value);
- No gender restrictions;
- The clinical diagnosis is acute ischemic stroke of the anterior circulation, and the site of acute occlusion of the responsible vessel is located in the intracranial segment of the internal carotid artery and the M1 or M2 segment of the middle cerebral artery;
- The symptoms and signs are consistent with acute anterior circulation ischemic stroke, NIHSS≥6;
- The time from onset to endovascular thrombectomy of acute ischemic stroke is within 24 hours;
- Indications for endovascular thrombectomy of acute ischemic stroke: ① ASPECTS score ≥ 6 points, within 6 hours of onset; ② 6-16 hours after onset, meeting DEFUSE-3 criteria (infarct core volume < 70 mL, mismatch rate ≥ 1.8 and mismatch volume > 15 mL) or DAWN criteria (NIHSS ≥ 10 and infarct core volume < 31 mL); Or NIHSS ≥ 20 and infarct volume 31-51 mL); ③ Within 16-24 hours of onset, meet DAWN criteria (NIHSS ≥ 10 points and infarct core volume < 31mL); Or NIHSS ≥ 20 points and infarct volume 31-51 mL)
- The mRS score before stroke is 0-1 points;
- Written informed consent provided by the patients or their legal relatives.
Who cannot join
- General exclusion criteria:
- Clinical manifestations suggest the presence of intracranial cerebral parenchymal hemorrhage or subarachnoid hemorrhage (even if imaging results are normal);
- During a stroke, accompanied by epilepsy, an accurate NIHSS score cannot be obtained;
- Accompanied by coma or mental disorders, it may interfere with the assessment of neurological function;
- History of allergy to iodinated contrast agents or history of anaphylactic shock;
- Baseline blood glucose<50mg/dL (2.78mmol) or>400mg/dL (22.20mmol);
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- Acceptable fingertip blood glucose results
- Baseline platelet count<50 × 10^9/L;
- Recently (i.e. within 30 days prior to inclusion in the study), there has been a history of significant gastrointestinal or other clinically significant bleeding; Active bleeding, abnormal coagulation factors, or bleeding tendency (taking anticoagulant drugs with INR ≥ 3 or PT ≥ 3 × ULN; if the researcher believes that the subject has no coagulation dysfunction, there is no need to wait for coagulation test results to determine whether to enroll);
- During a stroke, there may be fever or active infections that require systemic treatment (such as active pulmonary tuberculosis);
- History of chronic heart failure with NYHA criteria>1; Uncontrolled hypertension (systolic blood pressure>180mmHg or diastolic blood pressure>105mmHg after standardized treatment), hypotension (systolic blood pressure ≤ 100mmHg after standardized treatment), unstable angina, myocardial infarction, or bypass or stent surgery within 6 months;
- Accompanied by pulmonary diseases such as chronic obstructive pulmonary disease, tuberculosis, pneumonia, pneumothorax, atelectasis, pulmonary fibrosis, bronchopulmonary dysplasia, pleural effusion, acute respiratory distress syndrome, irregular breathing, etc;
- Severe liver and kidney dysfunction, including but not limited to: cirrhosis, hepatic encephalopathy, ascites, renal failure or uremia (Ccr<25ml/min), hepatorenal syndrome, etc;
- Pregnant or lactating women;
- Patients with acute stroke within 48 hours after percutaneous cardiovascular and cerebrovascular intervention and major surgery;
- Currently participating in interventional clinical trials and using research drugs or medical devices;
- Participants may not be able to complete this study due to other reasons or may not be considered eligible for inclusion by the researchers;
- Image exclusion criteria:
- CTA/MRA/DSA shows excessive vessel curvature, which may hinder the delivery of interventional instruments;
- Suspected cerebral vasculitis based on medical history and CTA/MRA/DSA;
- Suspected aortic dissection based on medical history and CTA/MRA/DSA;
- CTA/MRA/DSA confirmed multi vessel regional occlusion (such as bilateral anterior circulation or anterior/posterior circulation, extracranial carotid artery with intracranial tandem lesions), or clinical evidence of bilateral infarction or multi regional infarction;
- CTA/MRA/DSA confirms moyamoya disease or moyamoya syndrome;
- CT/MRI confirms significant effect of midline shift;
- CT/MRI confirms the presence of intracranial tumors (excluding small meningiomas);
- CT/MRI confirms the presence of intracranial hemorrhage.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100053
Yang Zhang, MD, 010-83911991, zy1192268729@163.com
About this study
Official title: Intra-arterial Hypothermic Magnesium Sulfate Infusion in Combination with Endovascular Thrombectomy in Acute Ischemic Stroke: a Safety Study
The primary objective of this study is to estimate the safety of intra-arterial hypothermic magnesium sulfate infusion after endovascular thrombectomy in patients with acute ischemic stroke
- Conditions
- Acute Ischemic Stroke
- Being tested
- Intra-arterial hypothermic magnesium sulfate infusion, Endovascular thrombectomy, Intravenous thrombolysis
- Keywords
- Acute ischemic stroke, Intra-arterial hypothermic infusion, Neuroprotection, Endovascular Thrombectomy, Magnesium sulfate
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-arterial hypothermic magnesium sulfate infusionProcedure or surgery
According to patient's weight, magnesium sulfate (MgSO4) will be diluted to 330 ml 4°C saline solution (0.6μmol/kg/ml). During the thrombectomy procedure, a micro-catheter will be advanced until it reaches beyond the clot responsible for the ischemic symptoms, then cold 30 ml MgSO4 solution will be infused into the ischemic territory at 15 ml/min through the micro-catheter. After that, thrombectomy with a stent retriever will be performed to recanalize the occluded vessel as soon as possible. Immediately after successful thrombectomy, cold MgSO4 solution will be re-infused into the ischemic brain tissue through the catheter at a rate of 30 ml/min for 10 min.
Endovascular thrombectomyProcedure or surgery
All patients that are eligible for endovascular thrombectomy will receive this surgery in aim to remove thrombus and restore reperfusion.
Intravenous thrombolysisDrug
All patients that are eligible for Intravenous thrombolysis will receive 0.9mg/kg rt-PA in aim to remove thrombus and restore reperfusion
| Study group | Role | What they receive |
|---|---|---|
| Intra-arterial hypothermic magnesium sulfate infusion | Experimental | Patients will receive intra-arterial hypothermic magnesium sulfate infusion after endovascular thrombectomy. Receives: Procedure: Intra-arterial hypothermic magnesium sulfate infusion; Procedure: Endovascular thrombectomy; Drug: Intravenous thrombolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality at 90 days
Measured: 90 days after intra-arterial hypothermic magnesium sulfate infusion
Secondary outcomes (4)
Grade 3-5 Treatment Emergent Adverse Event (TEAE) related to intervention occurring during treatment period
TEAE includes but not limited to cardiovascular system response, abnormal electrocardiogram, water-electrolyte imbalance, core temperature decreasing, vascular spasm, shiver, infect, disturbance of consciousness.
Measured: Within 72 hours after intra-arterial hypothermic magnesium sulfate infusion
All Treatment Emergent Adverse Event (TEAE) related to intervention occurring during treatment period
Measured: Within 72 hours after intra-arterial hypothermic magnesium sulfate infusion
All Treatment Emergent Adverse Event (TEAE) occurring during treatment period
Measured: Within 72 hours after intra-arterial hypothermic magnesium sulfate infusion
The proportion of symptomatic/asymptomatic intracranial hemorrhage within 24 h
Measured: Within 24 hours after intra-arterial hypothermic magnesium sulfate infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start10 Jan 2025 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Xunming,MD,PhD, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06760195
- Sponsor's protocol ID
- Hypo-Mag
- Acronym
- Hypo-Mag
- Status last verified
- Dec 2024
- First submitted
- 3 Jan 2025
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-arterial Hypothermic Magnesium Sulfate Infusion in Combination with Endovascular Thrombectomy in Acute Ischemic Stroke: a Safety Study
- ClinicalTrials.gov ID
- NCT06760195
- Acronym / sponsor ID
- Hypo-Mag / Hypo-Mag
- Conditions
- Acute Ischemic Stroke
- Keywords
- Acute ischemic stroke, Intra-arterial hypothermic infusion, Neuroprotection, Endovascular Thrombectomy, Magnesium sulfate
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 10 Jan 2025 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 6 Jan 2025 (actual)
- 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.
The primary objective of this study is to estimate the safety of intra-arterial hypothermic magnesium sulfate infusion after endovascular thrombectomy in patients with acute ischemic stroke
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intra-arterial hypothermic magnesium sulfate infusion | Experimental | Procedure: Intra-arterial hypothermic magnesium sulfate infusion, Procedure: Endovascular thrombectomy, Drug: Intravenous thrombolysisPatients will receive intra-arterial hypothermic magnesium sulfate infusion after endovascular thrombectomy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age range of 18-80 years old (including critical value);
- No gender restrictions;
- The clinical diagnosis is acute ischemic stroke of the anterior circulation, and the site of acute occlusion of the responsible vessel is located in the intracranial segment of the internal carotid artery and the M1 or M2 segment of the middle cerebral artery;
- The symptoms and signs are consistent with acute anterior circulation ischemic stroke, NIHSS≥6;
- The time from onset to endovascular thrombectomy of acute ischemic stroke is within 24 hours;
Key exclusion criteria (26 listed)
- Clinical manifestations suggest the presence of intracranial cerebral parenchymal hemorrhage or subarachnoid hemorrhage (even if imaging results are normal);
- During a stroke, accompanied by epilepsy, an accurate NIHSS score cannot be obtained;
- Accompanied by coma or mental disorders, it may interfere with the assessment of neurological function;
- History of allergy to iodinated contrast agents or history of anaphylactic shock;
- Baseline blood glucose<50mg/dL (2.78mmol) or>400mg/dL (22.20mmol);
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 |
|---|---|---|
| Intra-arterial hypothermic magnesium sulfate infusionAccording to patient's weight, magnesium sulfate (MgSO4) will be diluted to 330 ml 4°C saline solution (0.6μmol/kg/ml). During the thrombectomy procedure, a micro-catheter will be advanced until it reaches beyond the clot responsible for the ischemic symptoms, then cold 30 ml MgSO4 solution will be infused into the ischemic territory at 15 ml/min through the micro-catheter. After that, thrombectomy with a stent retriever will be performed to recanalize the occluded vessel as soon as possible. Immediately after successful thrombectomy, cold MgSO4 solution will be re-infused into the ischemic brain tissue through the catheter at a rate of 30 ml/min for 10 min. | Procedure or surgery | Intra-arterial hypothermic magnesium sulfate infusion |
| Endovascular thrombectomyAll patients that are eligible for endovascular thrombectomy will receive this surgery in aim to remove thrombus and restore reperfusion. | Procedure or surgery | Intra-arterial hypothermic magnesium sulfate infusion |
| Intravenous thrombolysisAll patients that are eligible for Intravenous thrombolysis will receive 0.9mg/kg rt-PA in aim to remove thrombus and restore reperfusion | Drug | Intra-arterial hypothermic magnesium sulfate infusion |
Primary outcome
Mortality at 90 days
Time frame: 90 days after intra-arterial hypothermic magnesium sulfate infusion
4 secondary outcomes
Grade 3-5 Treatment Emergent Adverse Event (TEAE) related to intervention occurring during treatment period
Time frame: Within 72 hours after intra-arterial hypothermic magnesium sulfate infusion
All Treatment Emergent Adverse Event (TEAE) related to intervention occurring during treatment period
Time frame: Within 72 hours after intra-arterial hypothermic magnesium sulfate infusion
All Treatment Emergent Adverse Event (TEAE) occurring during treatment period
Time frame: Within 72 hours after intra-arterial hypothermic magnesium sulfate infusion
The proportion of symptomatic/asymptomatic intracranial hemorrhage within 24 h
Time frame: Within 24 hours after intra-arterial hypothermic magnesium sulfate infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Intra-arterial hypothermic magnesium sulfate infusion, Endovascular thrombectomy and Intravenous thrombolysis in people with Acute Ischemic Stroke, run by Capital Medical University at 1 site in China.
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 8 inclusion and 26 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: opening soon, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xunming Ji, MD, PhD (010-83198952, jixm@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality at 90 days (time frame: 90 days after intra-arterial hypothermic magnesium sulfate infusion). 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 7 Jan 2025.