Using neuroprotective agents and cold saline during stroke treatment

Intra-Arterial Administration of Neuroprotective Agents and Cold Saline at Time of Recanalization for Acute Ischemic Stroke Due to Large Vessel Occlusion

This study is testing whether using a mix of protective treatments, including cold saline, during stroke surgery can help improve recovery for people with a type of severe stroke.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: Northwell Health (other)
• Locations: 1 site (Manhasset, New York)
• Trial ID: NCT05032781 on ClinicalTrials.gov

What this trial studies

This phase I clinical trial investigates the safety and feasibility of administering a combination of neuroprotective agents, including cold saline, minocycline, and magnesium, directly into the affected artery during mechanical thrombectomy for acute ischemic stroke caused by large vessel occlusion. The study aims to address the gap between successful vessel recanalization and poor clinical outcomes by providing targeted therapy to protect damaged brain tissue. Participants will be closely monitored for adverse effects and clinical outcomes compared to historical controls.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-90 who are undergoing mechanical thrombectomy for acute ischemic stroke due to large vessel occlusion.

Not a fit: Patients with large vessel occlusions in areas not eligible for endovascular intervention or those who do not meet the criteria for thrombectomy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve long-term functional outcomes for patients suffering from ischemic strokes.

How similar studies have performed: While the approach of using neuroprotective agents in stroke treatment is promising, this specific combination and method of delivery is novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

* Male or female aged 18-90
* Signed and dated informed consent and IRB form by the patient or legally authorized health care proxy.
* Diagnosis of acute ischemic stroke due to large vessel occlusion based on clinical and radiographic evidence as determined and documented by the Stroke Neurology team at Northshore University Hospital.
* Participants must meet criteria for intra-arterial thrombectomy as determined and documented by the Stroke Neurology and Interventional Neuroradiology attending physicians at Northshore University Hospital.
* Angiography must reveal a thromboembolism which is completely occluding flow within the intracranial portion of the internal carotid artery, the M1 or proximal M2 portions of the middle cerebral artery.

Exclusion Criteria:

* Patients that do not otherwise meet criteria for endovascular intervention
* Large vessel occlusion of the anterior cerebral artery, posterior circulation, or distal M2 portion of the middle cerebral artery.
* Recanalization of only TICI 0-2A.
* Pregnant or lactating women.
* Therapeutic anticoagulation prior to presentation.
* Known allergic reactions to contrast dye or components of minocycline (tetracycline) or magnesium sulfate.
* Patients with a known prior diagnosis of heart block or prior myocardial infarction (increased risk of adverse reaction to MgSO4).
* Renal insufficiency (creatinine \> 2.5 mg/dL)
* Severe hepatic functional impairment (AST \> 10xULN, bilirubin \> 5xULN)
* Systemic lupus erythematosus
* Idiopathic intracranial hypertension

Where this trial is running

Manhasset, New York

• North Shore University Hospital — Manhasset, New York, United States (RECRUITING)

Study contacts

• Principal investigator: Thomas W Link, MD, MS — Northwell Health
• Study coordinator: Thomas W Link, MD, MS

Conditions: Stroke, Ischemic, Ischemic stroke, Large vessel occlusion, Mechanical thrombectomy, Neuroprotection, cold saline, Minocycline, Magnesium sulfate