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Stroke: Clinical Trials

The U-M Comprehensive Stroke Program is actively involved in several clinical research projects, including:

Brain Attack Surveillance in Corpus Christi (BASIC)
Funding Source: National Institutes for Health
Principal Investigators: Lynda Lisabeth, Ph.D. /Lewis Morgenstern, M.D.
BASIC is a stroke surveillance project in Nueces County, Texas. This population-based study compares stroke in Mexican-American and non-Hispanic whites throughout the county. BASIC also examines race/ethnic differences in acculturation and access to care.

RESPECT Trial
Funding Source: AGA Medical
Local PI: Lewis Morgenstern, MD
The purpose of this study is to compare device closure of patent foramen ovale (PFO) with medications in people with a history of cryptogenic stroke (stroke from undetermined cause).

Combined Approaches to Lysis Utilizing Eptifibatide and rt-PA in Acute Ischemic Stroke – Enhanced Regimen
Funding Sources
: NIH
Local Principal Investigator: William Meurer, MD.
CLEAR will evaluate the safety of a glycoprotein IIb/IIIa antagonist (eptifibatide) in combination with rt-PA when administered within three hours of acute ischemic stroke.

Continuous positive airway pressure for stroke and obstructive sleep apnea.
Funding Sources: NIH
PI: Devin Brown, M.D.
This pilot clinical trial tests the tolerability and effectiveness of continuous positive airway pressure for stroke in patients with obstructive sleep apnea. The study is a randomized, controlled, blinded trial in patients with recent stroke.

Cardiac MRI in stroke
Funding Sources: University of Michigan Cardiovascular Center
PI: Darin Zahuranec, MD
This pilot trial is investigating the accuracy of cardiac MRI in improving the detection of emboli (clots) that may cause stroke.

Familial Intracranial Aneurysm Study
Funding Source
: NIH/National Institute of Neurological Disorders and Stroke
This study will identify susceptibility genes that are related to the formation of intracranial aneurysms. IA ruptures occur in 16,000 to 17,000 people in the U.S. annually; nearly half of affected persons die within the first 30 days. An additional 6,000 to 7,000 people with unruptured IAs are identified each year. Research indicates a genetic component in the development of IAs, but specific loci affecting the risk of IA have not been identified.

Gender and Acute Stroke Presentation: Do women with stroke present differently from men with stroke?
Funding Sources
: University of Michigan Office for the Vice President of Research, Institute for Research on Women and Gender and Department of Neurology
PI: Lynda Lisabeth, Ph.D.
A recent study found that women present more often with non-traditional stroke symptoms, perhaps contributing to a delay in treatment. This finding has public health implications for acute stroke therapy as the recognition of gender differences may result in faster evaluation of female patients, an important point since approved therapy for stroke requires very timely administration. The goal of this pilot project is to investigate gender differences in acute stroke symptoms for individuals presenting to the University of Michigan Hospital.

Genetic Risk Factors for Medication-Related Hemorrhagic Stroke
Funding Source
: NIH
GOCHA seeks to elucidate potential genetic and clinical risk factors for warfarin-related ICH. Enormous clinical benefit could be conferred by an improved ability to predict an individual's risk for warfarin-related ICH. Individuals with the highest risk of ICH could be spared anticoagulation therapy for all but the most compelling indications, and individuals at particularly low risk for ICH could be more aggressively anticoagulated. Finally, perhaps the most compelling result of this study will be an improved ability to quantify risk for warfarin-related ICH that will mitigate the reluctance of physicians to advise patients to undertake anticoagulation therapy.

Title: Dizziness in the Emergency Department: A population based project.
Funding source: NIH K23
PI: Kevin A. Kerber,MD
Brief description: This study aims to determine the quality of care received by patients who present for dizziness to the Emergency Department. In addition, burden of illness and healthcare utilization will be measured. The infrastructure of the BASIC project is used to capture dizziness presentations.

Title: Emergency Physician Leadership in Acute Stroke Care in a Bi-ethnic Community
Funding Source: Emergency Medicine Foundation

PI: William J. Meurer, MD
In this study, Dr. Meurer will be examining barriers to the delivery of tPA in acute stroke patients in a representative bi-ethnic community. The findings from this study will be used to design a rigorous intervention to improve the outcomes of stroke patients by optimizing the way that emergency providers (paramedics, nurses, doctors) provide care.

For additional information about clinical trials throughout the University of Michigan Health System, visit umclinicalstudies.org.