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Cerebrovascular Disease And Stroke

ATACH II

Antihypertensive Treatment of Acute Cerebral Hemorrhage

Summary: This is a phase III randomized controlled trial to determine aggressive versus standard blood pressure management improves patient outcomes who have suffered from hypertensive intracerebral hemorrhage.

Start Date: August 2010

End Date: July 2015 - over, no longer recruiting

Funding Source: NIH-NINDS

Principal Investigators: Steven R. Levine, MD (UHB) and Susan W. Law, DO, MPH (KCH)

Contact: Sarah Weingast (UHB) and Bryce Petty (KCH)

BRAINS

Bringing Recognition And Awareness To Inner-City Neighborhoods About Stroke

Summary: This is a survey-based study looking to determine the change in stroke knowledge with age. This study will look collect results from pre-teens to adults (ages 9 and up) in the community to assess the beliefs and concepts that pre-teens, teens, and adults have about what a stroke is.

Start Date: July 2015

End Date: over, no longer recruiting

Funding Source: American Heart Association

Principal Investigator:  Steven R. Levine, MD

Co-Investigators: Sara Wertenteil, Sarah Weingast, Dimitre Stefanov, PhD, and Dee Burton, PhD

Contact: Sarah Weingast (718) 270-1263

ECLIPSE

Exploring CLInical and neuroimaging correlates of Post-Stroke fatiguE

Summary: To estimate the frequency and course and of PSF in a consecutive cohort of ischemic stroke patients at baseline, in the early phase of stroke (within a week from the event or at discharge whichever comes first), and at 1, 3 and 6 months). Also, to explore the relationship between neuroimaging (primary lesion location lesion location and presence of silent brain infarcts and leukoaraiosis) and clinical variables (age, race/ethnicity, gender, stroke severity, vascular risk factors (diabetes, hypertension, hypercholesterolemia, obesity, cigarette smoking) and comorbidities with the occurrence of PSF.

Start Date: June 18 2014

End Date: Ongoing

Funding Source: Investigator initiated

Principal Investigators: Steven R. Levine, MD and Clotilde Balucani, MD, PhD

Contact: Nadege Gilles (718) 270-7786

EPSF

Exploring Post-Stroke Fatigue

Summary: To assess the frequency of PSF in a minority, urban population and the relationship between post stroke fatigue and depression. Also, to explore the patient perception of PSF and how it affects their quality of life.

Start Date: May 2 2014

End Date: Ongoing

Funding Source: Investigator initiated

Principal Investigators:  Steven R. Levine, MD and Clotilde Balucani, MD, PhD

Contact: Nadege Gilles (718) 270-7786

HAMLET

To treat or not to treat minor stroke and rapidly improving stroke symptoms? The Hamlet Survey Study

Summary: This survey-based study aims to identify factors affecting stroke treating physicians' decisions to treat or not to treat minor stroke and rapidly improving stroke symptoms (RISS) with recombinant tissue Plasminogen Activator (rt-PA). Active in writing up the paper and the survey is over.

Start Date: August 2015

End Date: 2017

Funding Source: Genentech

Principal Investigator:  Steven R. Levine, MD

Co-Investigator: Clotilde Balucani, MD, PhD

Contact: Sarah Weingast (718) 270-1263

Macrovascular And Microvascular Disease In Vascular Cognitive Impairment

Principal Investigator:  Howard Crystal, MD, Alison Baird, MD, PhD, and Hua Yu, MD

MAPPS

Mobile Apps For Stroke Survivors And Caregivers

Summary: The primary objective is to develop a stroke mobile application for stroke survivors to help them manage their health after a stroke event. This project was divided into 4 phases Focus groups, National survey, usability testing, and phone interviews. From the results of these phases a customizable mobile app has been developed for smart phone use for stroke survivors (SS) specifically based on their feedback and needs. It provides resources, support groups, fitness & diet, scheduling, "my medical information". The app was designed to consider age, gender, ethnicity, and race. We are now beta testing our final product to optimize the features of the mobile app. Our collaborators on this study include National Stroke Association and Arthur Ashe Institute.

Start Date: July 2012

End Date: January 2017 - no longer recruiting, manuscripts in preparation

Funding Source: PCORI

Principal Investigator:  Steven R. Levine, MD

Co-Investigators: Ruthe Browne, ScD and Marilyn White-Fraser, MD

Contact: Nadege Gilles (718) 270-7786

NAVIGATE ESUS

Rivaroxaban Versus Aspirin in Secondary Prevention of Stroke and Prevention of Systemic Embolism in Patients With Recent Embolic Stroke of Undetermined Source

Summary: This is a study in patients who recently had a brain attack (stroke) and in whom no clear cause of the stroke could be identified. These strokes are likely due to a blood clot and therefore, can be called embolic stroke of undetermined source. The abbreviation is ESUS. The study will compare 2 blood thinners. Patients will be randomly assigned to either Rivaroxaban 15 mg or Aspirin 100 mg and the study is intended to show, if patients given rivaroxaban have fewer blood clots in the brain (stroke) or in other blood vessels.

Start Date: November 2015

End Date: over, no longer recruiting

Funding Source: Bayer

Principal Investigator:  Steven R. Levine, MD

Co-Investigators: Adrian Marchidann, MD, Susan W. Law, DO, MPH, and John T. Kassotis, MD

Contact: No longer enrolling

POINT

Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke

Summary: This is a phase III randomized controlled trial to determine which of two anti-platelet regimens are superior in reducing vascular events following a stroke or high risk transient ischemic attack (TIA).

Start Date: October 2009

End Date: Active, still recruiting

Funding Source: NIH-NINDS

Principal Investigators:  Adrian Marchidann, MD (UHB) and Susan W. Law, DO, MPH (KCH)

Contact: Sarah Weingast (UHB) and Bryce Petty (KCH)

PRISMS

A Study of the Efficacy and Safety of Activase (Alteplase) in Patients With Mild Stroke

Summary: Patients will be randomized in a 1:1 ratio to receive within 3 hours of last known well time either 1) one dose of IV Activase and one dose of oral aspirin placebo or 2) one dose of IV Activase placebo and one dose of oral aspirin 325 mg. The data is being written up and is to be presented at ISC in Jan. 2018.

Start Date: January 2015

End Date: Unknown - over, no longer recruiting

Funding Source: Genentech

Principal Investigator:  Steven R. Levine, MD

Co-Investigators: Adrian Marchidann, MD and Susan W. Law, DO, MPH

Contact: Nadege Gilles (718) 270-7786

REMOTE

Validity and reliability of acute stroke head CT reading via hand-held devices

Summary: Telemedicine has facilitated an increase in the use of intravenous recombinant tissue plasminogen activator (rt-PA) for acute ischemic stroke and is increasingly offered to provide stroke expertise to remote and underserved areas (Schwamm et al. 2009a and b). There is limited data on the accuracy of stroke neurologists' use of telemedicine to read head computed tomography scans (CT) (Johnston & Worrall 2003, Schwamm et al 2003) and no published data using hand-held devices (such as iPhones, iPADs, or Droids). Currently, the FDA has approved use and reimbursement for telemedicine and teleradiology performed on PCs, laptops, and workstations. However, there has been no ruling yet for the use of hand-held devices in clinical medicine and for services that can be reimbursed, in part because the FDA wants to see data that hand-held devices can provide. The paper is being written.

Start Date: 2012

End Date: Analysis Only - over, no longer recruiting

Funding Source: Calgary Scientific

Principal Investigator:  Steven R. Levine, MD

Co-Investigators: Alison E. Baird, MD, PhD

Contact: Sarah Z. Weingast (718) 270-1263

SHINE

Stroke Hyperglycemia Insulin Network Effort Trial

Summary: This is a study in patients who recently had a brain attack (stroke) to determine if aggressive glycemic control decreases stroke-related mortality.

Start Date: June 2013

End Date: Active, still recruiting

Funding Source: NIH-NINDS

Principal Investigators:  Steven R. Levine, MD and Jennifer Martindale, MD (KCH)

Co-Investigators: Adrian Marchidann, MD and Susan W. Law, DO, MPH

Contact: Sarah Weingast (UHB) and Bryce Petty (KCH)

spFRET Molecular Profiling mRNA

Summary: Finding molecular markers for stroke diagnosis.

Principal Investigator:  Alison Baird, MD, PhD