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NCT05032781 · ClinicalTrials.gov registry record · Phase 1
Intra-Arterial Neuroprotective Agents and Cold Saline in Ischemic Stroke Intervention
A Phase 1 study of Stroke, Ischemic, sponsored by Northwell Health.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT05032781 is a Phase 1 study of Stroke, Ischemic that is actively recruiting participants, run by Northwell Health. The registered enrollment target is 24 participants, below the 289-participant average among 33 other Stroke, Ischemic trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05032781, a Phase 1 study of Stroke, Ischemic, is actively recruiting participants, sponsored by Northwell Health.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
Ischemic stroke is the leading cause of long-term disability in the United States. Endovascular intervention with mechanical thrombectomy has become the standard of care for acute large vessel occlusion (LVO) stroke since multiple clinical trials demonstrated improved long-term clinical outcomes with treatment. However, despite high rates of successful vessel recanalization and thus reperfusion of ischemic brain tissue in current practice, many patients continue to suffer debilitating strokes and poor long-term functional outcome. Pharmacologic neuroprotection could potentially present a means of addressing this mismatch in radiologic vs. clinical outcomes by protecting and salvaging damaged brain tissue. Intra-arterial delivery of a cocktail of neuroprotective therapy at the time of endovascular reperfusion would provide immediate, targeted therapy directly to the damaged brain territory. Hypothermia, minocycline and magnesium can target multiple facets of the complex ischemic injury cascade, and have each demonstrated neuroprotection in multiple preclinical models. This is a phase I trial that aims to demonstrate safety and feasibility of administering cold saline, minocycline, and magnesium sulfate intra-arterially immediately after thrombectomy in stroke interventions.
Conditions Studied
Interventions
- DRUG Intra-arterial cold saline, minocycline, and magnesium
Study Locations (1)
New York
- North Shore University Hospital - Manhasset
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2021-06-01 |
| Est. Completion | 2025-09 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05032781
The ClinicalTrials.gov registry entry for NCT05032781 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 289-participant average among 33 other Stroke, Ischemic trials with a reported enrollment target (92% lower). The listed sponsor is Northwell Health, which has 370 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Stroke, Ischemic appearing as the primary indexed condition, and to 1 intervention - of which Intra-arterial cold saline, minocycline, and magnesium is the first listed.
NCT05032781 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT05032781 about?
NCT05032781 is a clinical study titled "Intra-Arterial Neuroprotective Agents and Cold Saline in Ischemic Stroke Intervention". Ischemic stroke is the leading cause of long-term disability in the United States. Endovascular intervention with mechanical thrombectomy has become the standard of care for acute large vessel occlusion (LVO) stroke since multiple clinical trials demonstrated improved long-term clinical outcomes wit...
What is the current status of trial NCT05032781?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2021-06-01. Estimated completion is 2025-09.
What conditions does trial NCT05032781 study?
This clinical trial studies the following conditions: Stroke, Ischemic.
What interventions are being tested in trial NCT05032781?
The interventions under investigation include: Intra-arterial cold saline, minocycline, and magnesium (DRUG).
Who is sponsoring clinical trial NCT05032781?
This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05032781 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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