U of M named one of 25 regional stroke centers that will revolutionize stroke clinical research

Thursday, December 19, 2013

[News release adapted from National Institutes of Health]

The University of Minnesota has been named one of 25 institutions that will lead a nationwide network of regional stroke centers as part of a new, NIH-driven effort to reduce the impact of stroke across the United States.

Within the new program, the 25 primary sites will work with nearby satellite facilities, capitalize on teams of researchers representing every medical specialty needed for stroke care and will address the three prongs of stroke research: prevention, treatment and recovery. 

“The new system is intended to streamline stroke research by centralizing approval and review, lessening time and costs of clinical trials, and assembling a comprehensive data sharing system,” said Petra Kaufmann, M.D., the associate director for clinical research at the National Institute of Neurological Disorders and Stroke (NINDS).

The 25 centers are strategically placed in every region of the country. The University of Minnesota was selected because it has a great reputation of academic excellence, dedication to research and advancement of medical knowledge. The University also demonstrated a full cadre of specialties involved in stroke care including: emergency medicine, neurosurgery, interventional neuroradiology, vascular neurology, neurointensive care, neuroimaging, stroke rehabilitation and pediatric neurology. 

The University of Minnesota stroke center site’s goal is to advance therapies and care available for patients with cerebrovascular disease. Conducting clinical research to test potential therapies is an important step in testing the value of new ideas, drugs or devices coming from basic research, or finding new use for existing ones.

“Stroke is a major cause of disability and death around the world and in Minnesota and despite progress in medical therapies available today, we are still a long way from being able to achieve the desired cures and recovery,” said Mustapha Ezzeddine, M.D., associate professor in the Department of Neurology and principal investigator of the University of Minnesota stroke center site. “By uncovering new treatments for stroke we hope that the new network will also lead to improved therapies in these other diseases such as traumatic brain and spine injuries.” 

Ezzeddine also said the research will focus on three main areas: 1) acute treatments in the Emergency Department, the Neurocritical Care Unit, the Neurointerventional suite or the operating room, 2) secondary prevention of stroke, and 3) enhancing recovery following the injury to the brain.

Each center will receive five-year funding, with $200,000 in research costs and $50,000 for training stroke clinical researchers per year over the first three years, and additional funds driven by the completion of milestones. The University of Cincinnati will manage the national clinical coordinating center, which will oversee and coordinate the institutional review board and master trial agreements for all of the regional centers. NIH will announce the award of a national data management center in February.

A stroke occurs when blood flow to the brain is interrupted, causing brain cells in the immediate area to die because they stop getting oxygen. Stroke can also occur when a vessel breaks and bleeds into the brain. The number of new strokes reported each year is 795,000, making stroke the fourth leading cause of death in the US. Because stroke is age-linked the incidence is expected to rise rapidly in the next decade.

NIH StrokeNet investigators, working with the broader stroke community, will propose, develop and conduct stroke protocols to be administered within the network and train the future generation of clinical researchers in stroke.

Historically, the model for stroke clinical trials was to complete large teams of personnel and infrastructure, which were then disassembled once the trial was completed.  This led to delays in patient recruitment and additional costs when new trials were initiated, with some stroke clinical trials lasting many years longer than anticipated and costing millions of dollars more than the original estimate.

The network concept evolved from an NINDS planning effort in which stroke experts were asked what is most needed to reduce death and disability due to stroke in the United States. They called for a nationwide stroke network that would allow for a more seamless transition between early safety and efficacy trials and Phase II and III clinical trials. 

“NIH StrokeNet will allow the most promising therapies to quickly advance to the clinic, to improve prevention, acute treatment, or rehabilitation of the stroke patient,” said Walter J. Koroshetz, M.D., NINDS deputy director. “We need to have a balance of approaches to decrease the burden of illness due to stroke.”

“Our goal for the NIH Stroke Centers Network is to initiate four to five NINDS-funded exploratory Phase I and II stroke clinical trials, and two to four Phase III trials over the next five years. This is a major challenge which we believe the stroke research community will embrace,” said Scott Janis, Ph.D., NINDS program director of the NIH StrokeNet. 

For more information about stroke, please visit: stroke.nih.gov.