(SALT LAKE CITY) University of Utah Hospital has officially been named by the National Institutes of Health (NIH) as a member of a unique network of regional stroke centers across the country that will work with nearby satellite facilities, have 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).
NINDS, which will fund and manage the NIH Stroke Trials Network, or NIH StrokeNet, has a strong history of successful stroke clinical trials over the past 40 years, leading to some astonishing advances in treatment and prevention of the disease, including the first treatment for acute stroke, announced in 1995.
University of Utah Hospital, the first and only Comprehensive Stroke Center in the Intermountain West, is one of only 25 centers nationwide to be selected to participate in StrokeNet. Additionally, Jennifer Majersik, M.D., Director of the University of Utah Stroke Center, has been asked to serve on the NIH StrokeNet Executive Council, placing University of Utah Hospital at the forefront of decision making and governance for the new network.
Stroke is the number one cause of disability in the United States and we desperately need therapies to reduce the incidence of stroke and to improve therapy, says Dr. Majersik. University of Utah Hospital has long been a leader in stroke care, and to now be so involved with a national network dedicated to improving care across the country really solidifies our commitment that advancing stroke care in this region is a priority.
To be recognized, successful applicants demonstrated experience in stroke research and recruitment, including the ability to enroll underrepresented populations, and were required to offer access to the full cadre of specialties that are involved in stroke care. These include: emergency medicine, neurosurgery, interventional neuroradiology, vascular neurology, neurointensive care, neuroimaging, stroke rehabilitation and pediatric neurology.
Along with every designated StrokeNet Center, University of Utah Hospital 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.
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.
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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.
For more information about stroke, please visit: stroke.nih.gov.
NINDS is the nation's leading funder of research on the brain and nervous system. The NINDS mission is to reduce the burden of neurological disease a burden borne by every age group, by every segment of society, by people all over the world.
About the University of Utah Stroke Center: The University of Utah Stroke Center provides 24/7 access to a multidisciplinary team of fellowship-trained physicians who specialize in stroke, and is a regular recipient of the American Heart/Stroke Association's Get With The Guidelines Gold Performance Award. Widely recognized as the premier Stroke Receiving Facility in the Intermountain West, University of Utah Hospital is the first and only Certified Comprehensive Stroke Center in the region, and provides specialized stroke care to rural and underserved areas throughout the region via its Telestroke program.
About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.
The study was funded by the following NINDS grants: (centers) 1U10NS086497-01; 1U10NS086489-01; 1U10NS086513-01; 1U10NS086729-011U10NS086512-01; 1U10NS086607-01; 1U10NS086492-01; 1U10NS086467-01; 1U10NS086494-01; 1U10NS086608-01; 1U10NS086484-01; 1U10NS086728-01; 1U10NS086521-01; 1U10NS086606-01; 1U10NS086496-01; 1U10NS086526-01; 1U10NS086487-01; 1U10NS086535-01; 1U10NS086474-01; 1U10NS086528-01; 1U10NS086531-01; 1U10NS086533-01; 1U10NS086490-01; 1U10NS086525-01; (clinical coordinating center) 1U01 NS086872-01.
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