UC Receives $12.7 Million to Continue Coordinating Stroke Study

CINCINNATI—Stroke researchers at the University of Cincinnati (UC) will receive $12.7 million over the next four years from the National Institutes of Health (NIH) to continue coordinating an international study designed to compare treatment approaches for acute ischemic stroke.

An ischemic stroke, one of two main types of stroke, occurs when an artery to the brain is blocked. (The other main type of stroke, hemorrhagic stroke, is caused by excessive bleeding.) The standard FDA-approved approach to restoring blood flow to the brain is to administer the clot-busting drug tissue plasminogen activator (tPA) intravenously within three hours of stroke onset. The longer blood supply to the brain is blocked, the more likely long-lasting brain damage will occur.

The Interventional Management of Stroke (IMS III) trial, begun in 2005, compares a combined intravenous (IV) and intra-arterial (IA) treatment approach to restoring blood flow to the brain after an acute ischemic stroke to intravenous treatment with tPA alone. Intra-arterial treatment involves using a mechanical device to break up or remove the clot or delivering additional tPA via a catheter directly at the site of the clot blocking the artery.

Joseph Broderick, MD, Albert Barnes Voorheis Chair of Neurology at the UC College of Medicine, is the principal investigator for the IMS III trial. UC originally received $17.4 million from the NIH’s National Institute of Neurological Disorders and Stroke (NINDS) to coordinate the trial. Thomas Tomsick, MD, a professor of radiology at UC, is the principal interventionalist for the trial. The new, competitive renewal grant continues the trial into 2015.

UC researchers, including Broderick, played a leading role in developing and testing IV tPA as a treatment for stroke in the late 1980s and mid-1990s. Broderick also was one of the founding members of the Greater Cincinnati/Northern Kentucky Stroke Team, which was the first regional stroke team in the United States.

"While some of these intra-arterial devices are being used as part of standard practice in many hospitals worldwide, we still don’t know whether or not the combination of IV tPA and the devices improves patient outcomes better than IV tPA alone,” says Broderick. "And unless we do the trial, we will not know whether we are truly helping patients.”

Broderick says the study, originally intended to compare results in 900 U.S. and Canadian stroke patients, has been expanded to include Australia and Europe. The goal for patients enrolled remains at 900, with 571 patients enrolled as of Nov. 2, 2011.

"It’s important that trials like this are global,” Broderick says, "because what we learn about stroke or any disease should be applicable not only in the United States but across the world.”