NINDS
Overall P.I. Randolph S. Marshall, MS, MD
 Project 1 P.I. Mitchell SV Elkind, MS, MD
Project 2 P.I. Randolph S Marshall, MS, MD
Project 3 P.I. Bernadette Boden-Albala, PhD
Division of Stroke
Department of Neurology
Columbia University Medical Center
New York
Neuroprotection with Statin Therapy for Acute Recovery Trial (Neu-START)
Description:
The Neuroprotection with Statin Therapy for Acute Recovery Trial (Neu-START) is part of the Specialized Program on Translational Research in Acute Stroke (SPOTRIAS).
The goals of this trial are to determine if lovastatin in increasing doses from 1mg/kg to 10 mg/kg daily for 3 days beginning 12 hours after acute ischemic stroke can be administered safely; and to assess the pharmacokinetics of lovastatin administered at high doses. The PI of Neu-START is Dr. Mitchell Elkind.
Neu-START will enroll 33 patients with acute ischemic stroke presenting within 12 hours of onset. In the trial, investigators will treat the patients within 12 hours of symptom onset with short term high-dose lovastatin at escalating dosage. The escalating dosage levels will be 1, 3, 6, 8, and 10 mg/kg per day for 3 days. Lovastatin is in a class of drugs called statins, used for lowering cholesterol and preventing cardiovascular disease. Patients will be followed for 30 days for clinical and laboratory outcome events.
Inclusion:
- Age >18
- Satisfies the criteria for ischemic stroke: acute focal neurological deficit of likely ischemic vascular origin.
- Patient or legally authorized representative has provided written informed consent prior to study entry.
- Patient can receive the first treatment dose within 0-12 hours of stroke onset. For patients found with stroke on awakening, it will be assumed that the stroke occurred the last time that the patient was known to be normal.
- Patient has pretreatment brain CT scan compatible with ischemic stroke and excludes hemorrhagic and non-vascular etiologies of symptoms.
- Patients taking statins at time of stroke may be included.
For additional information about Neu-START, please contact the Project Coordinator, Dr.Tania E. Corporan at 212-305-7755, or email: tcorporan@neuro.columbia.edu.
fMRI
The primary Specific Aim for this study is to determine the network of brain regions at 24 hours after stroke that predicts subsequent recovery of function at 1 week and 3 months after stroke, independent of infarct size or stroke severity at onset. To pursue this goal, we are enrolling 100 first time stroke patients over the course of the 5-year study, and obtaining fMRI scans at 24-48 hours. From the imaging data we acquire in the acute period we will look prospectively at quantitative change in motor, language and visual-spatial deficits from 24 hours to 1 week and to 3 months to see whether the fMRI in the acute period can predict future stroke recovery.
SWIFT (Stroke Warning Information and Faster Treatment)
Our primary objective is to determine whether a three session culturally sensitive interactive educational program called SWIFT (Stroke
Warning Information and Faster Treatment) is more effective than usual care among a racially and ethnically diverse high-risk population. The goal of the intervention is to increase stroke knowledge, change behavior, and improve the time of arrival to the ED upon onset of stroke symptoms. To accomplish these aims we plan to randomize 1400 stroke/TIA patients and 1200 stroke free community residents into the SWIFT intervention versus usual care. All participants will be administered pre and post (30 days and 1 year) intervention stroke knowledge/behavior surveys. Comprehensive surveillance methodologies will measure arrival times for acute stroke among study participants for the length of the study. Our goal is to demonstrate that interactive strategies which promote the rapid identification of stroke symptoms; impart an urgency to obtain emergency medical treatment; and, aid in the navigation of emergency care will increase stroke awareness and decrease the individuals' response time to life saving stroke therapy.
The overall goals of SPOTRIAS are to enhance delivery of acute stroke patient care with a focus on high-risk, disadvantaged populations, train acute stroke translational researchers, and conduct 3 innovative acute stroke projects. Dr. Ralph L. Sacco is the Columbia Site PI for SPOTRIAS. The program is sponsored by The National Institute of Neurological Disorders and Stroke (NINDS).
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