StrokeNet is celebrating its 10-year anniversary!
In this interview, we explore UT StrokeNet's inception; its pivotal trials, innovative research initiatives, and adaptation during the COVID-19 pandemic; and its ambitious goals for the future.
A Decade of Advancing Stroke Care and Research: An Interview with UT StrokeNet Leaders
Established by the National Institutes of Health (NIH), StrokeNet serves as system for conducting high-quality, multi-center clinical trials across the United States. In this interview with Kinga Aitken, MPH CCRP, Project Manager for UT StrokeNet, and Jennifer Majersik, MD, MS, Vascular Division Chief and Stroke Center Director, we explore the inception of StrokeNet; its pivotal trials, innovative research initiatives, and adaptation during the COVID-19 pandemic; and its ambitious goals for the future.
Discover how this collaborative network has contributed to stroke care and research to reduce the burden of stroke across the Mountain West and the nation.
What is the StrokeNet?
The Stroke Trials Network, or StrokeNet, is a system backed by NIH that facilitates the creation and management of top-notch clinical trials across multiple centers. These trials aim to improve stroke prevention, treatment, and recovery. An additional goal of StrokeNet is to educate future stroke investigators and researchers. Through StrokeNet, all stroke experts are working together towards a mutual goal: to reduce the burden of stroke in this country and around the world. The network includes a National Coordinating Center at University of Cincinnati, a National Data Management Center at Medical University of South Carolina, 25 Regional Coordinating Centers (RCC) across the US, and >500 satellite-performing hospitals. Our patients can be proud because the University of Utah is the only RCC in the Mountain West.
Just this fall, the University of Utah was re-funded by the NIH as an RCC title for the third time in a row since network inception in 2013. Each RCC is tasked to work with local hospitals—academic and private, adult and pediatric, with various levels of experience and resources—in conducting stroke trials. UT StrokeNet has 12 satellite-performing hospitals (10 adult and two pediatric) in five states: UT, AZ, CO, MT, and ID. At the RCC, we are deeply committed to the success of our satellites, and we provide scientific leadership through both institutional backing and personal collaborations.
UT StrokeNet is celebrating its tenth anniversary. Can you explain how it got started? What was it like in 2013?
UT StrokeNet came to life in September 2013. Back then, stroke trials were challenged by many inefficiencies, such as multiple ethics review boards across the country and lengthy execution of trial agreements, which led to long and costly start-up times, slow or incomplete enrollment, and variable data quality. NIH StrokeNet proposed exciting new practices that were meant to address these exact challenges. They started using a single, centralized institutional review board (IRB), non-negotiable contracts, and a single electronic data capture system to reduce start-up times, enable study teams to focus on enrolling patients, and improve data quality and patient retention.
Our first five years of funding were heavily focused on the creation of a local network by engaging collaborators, creating a functional infrastructure, and improving the enrollment in existing trials. We brought together a total of eight adult and one pediatric hospitals in UT, Denver (CO), Grand Junction (CO), Phoenix (AZ), and Tucson (AZ). But those first five years weren’t solely focused on network building. We also did the work of trial enrollments. In fact, in the first five years, the UT StrokeNet sites participated in 10 stroke trials, enrolling 106 patients with 95% retention. In the second five years, UT StrokeNet continued to incorporate new sites, and despite the extraordinary disruption of the pandemic, participated in 15 StrokeNet trials by enrolling 366 patients. We are proud of these enrollment numbers and were re-funded for a third funding period based upon them.
UT StrokeNet has been actively involved in clinical trials. Can you mention some of the most impactful trials conducted in the last 10 years and their outcomes?
UT StrokeNet has been an active contributor to 15 of the 18 funded NIH StrokeNet trials.. EnDovascular ThErapy Following Imaging EvalUation for ISchemic StrokE (DEFUSE-3) attests to the success of the network. DEFUSE-3 was a prospective randomized Phase III multicenter controlled trial that aimed to assess how safe and effective thrombectomy (the surgical removal of a blood clot) is when it’s used on stroke patients outside of the usual time window. The trial enrolled 182 carefully selected patients at 38 centers in one year, which included two UT StrokeNet hospitals. Results were published in February 2018 and they changed the standard of care. This trial is one of the reasons why we are now able to treat many patients who present with the most severe types of stroke with clot retrieval up to 24 hours from stroke onset.
We have been successfully enrolling in the Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Study (CREST-2) since 2015. This primary prevention trial is for patients who haven’t had a stroke, but who are at higher risk due to a critical narrowing of the carotid artery. The study aims to identify the safest and most effective prevention method by comparing intensive medical management together with revascularization procedures (medical treatments that restore blood flow to the brain when that flow is limited or blocked) to intensive medical management alone. The revascularization procedures, as well as the medical management of stroke risk factors, have improved substantially in the last 20 years, but no research has been conducted to compare the treatment differences since then. The information from this study will help us learn the best way to prevent strokes in patients with narrow carotid arteries from plaque buildup.
The revascularization procedures, as well as the medical management of stroke risk factors, have improved substantially in the last 20 years, but no research has been conducted to compare the treatment differences. The information from this study will help us learn the best way to prevent strokes in patients with narrow carotid arteries from plaque buildup. To read about a patient’s remarkable experience in this trial, click here.
Finally, there is a new rehab trial that we are excited about. It is called Validation of Early Prognostic Data for Recovery Outcome after Stroke for Future, Higher Yield Trials (VERIFY), and it aims to understand how well we can predict arm recovery after stroke by performing non-invasive tests (brain imaging via magnetic resonance imaging, or MRI, and transcranial magnetic stimulation [TMS]) early after stroke. Learning this information will help us choose the right rehab therapies for our patients, quickly and accurately.
UT StrokeNet scientists have been engaged in diverse research areas. Could you highlight a few key findings or innovations resulting from their work in the past decade?
We’ve trained 11 scientists in clinical and translational stroke research, many resulting in published papers and grants (NIH K and R awards, as well as AHA awards), and we’re really proud of their work.
For example: rehabilitation psychologist Alexandra Terrill, PhD, and stroke neurologist Jennifer Majersik, MD, MS, are NIH-funded to test a positive psychology intervention that is meant to improve mood and well-being for couples in which one member has experienced a stroke at least three months prior. This study is called ReStoreD, and more info can be found here.
Robert Campbell, PhD (thrombosis and molecular medicine), and Frederik Denorme, PhD (Department of Neurology), have made significant contributions to pre-clinical stroke research by examining the roles of platelets in stroke patients and stroke mouse models. They have just published a landmark paper on a variant in a clotting gene that seems to explain some of the higher risk of stroke in African Americans, with certain antiplatelets showing promise for improving that risk.
Aaron Shoskes, DO, neurologist and current UT StrokeNet fellow, is also doing exciting work; he is currently exploring the use of national stroke databases to see if we can expand the criteria for patients to receive thrombolysis (a medication to dissolve blood clots) in cases of acute ischemic stroke, the non-bleeding type of stroke.
How has the COVID-19 pandemic affected the operations and research initiatives of UT StrokeNet, and how did you adapt to these challenges?
The COVID-19 pandemic had a huge dampening effect on clinical research nationally, and UT StrokeNet was no different. At first we had to nearly shut down research activities. This lasted until we could understand state and national guidance and implement new protocols designed for safety of research staff and patient participants. Because of the excellent national infrastructure and the dedicated local leadership in the Department of Neurology, we were able to quickly return to trial recruitment and safe continuation of ongoing trials.
One of the most important positive outcomes of the pandemic is that we now include remote consent and trial conduction processes as much as possible. In this way, we can allow patients to participate even during a pandemic, but also during a snowstorm or when transportation is expensive or not possible. This system lets us include distant family members in the process as well. The Mountain West population often lives so far from our urban centers, so we at UT StrokeNet are pushing the national conversation towards creating ways to include our rural and frontier patients. We’re really proud of our efforts in this area—and in fact, 25% of our trial enrollees in the last five years live in rural or metropolitan areas.
Collaboration is crucial. Could you discuss some key partnerships and collaborations that have advanced UT StrokeNet's work regionally and nationally?
Interdisciplinary collaborations are the backbone of the network as a whole. At the University of Utah, we ensure all relevant providers are engaged in any stroke trial we take on. For example, in CREST-2, patients can be randomized to one of two surgical arms. So we make sure that we have excellent and engaged partners in vascular neurology and neurosurgery. All our trial sites are similarly connected to providers across their institutions. Nationally, there are working groups to help design the best trials, and they include specialists from all fields, including neurology, neuroradiology, neurosurgery, emergency medicine, and rehabilitation. In the last few years, we’ve also added patients with stroke to these working groups, so that we can include their perspectives as well. It’s critical that if we’re going to enroll patients across the country into trials, we do so with all of the relevant voices at the table.
Looking ahead, what are UT StrokeNet’s key priorities and goals for the next decade, both in terms of patient care and research advancements?
StrokeNet’s goal is to find better treatments for stroke treatment, prevention, and recovery. We have made significant progress in the last ten years regarding treatment and prevention, but stroke recovery is lagging. National StrokeNet leaders, including Dr. Majersik, are working hard to close this gap by collaborating across disciplines to design innovative trials. The federal funding agency NIH is keenly aware of this gap and is at the table with us as we work through the complicated issues surrounding getting trials designed right. Ultimately, we hope that StrokeNet will reduce not only the amount of stroke in the US but also the disability from stroke after it happens.
Locally, UT StrokeNet intends to lead the national work being done to increase access to clinical stroke trials, whether that is for minority patients or patients living in rural and frontier areas. We will do this through innovative recruitment methods, particularly utilizing telemedicine and our existing TeleStroke network. Our current work includes the following initiatives:
- Improving stroke processes at TeleStroke sites through a national study that aims to standardize stroke process at non-academic TeleStroke sites.
- Working to better understand how non-English speaking patients receive their initial stroke care.
- Looking to expand our trial in post-stroke depression and resilience to more sites in the Mountain West.
We also hope to continue delivering clinical trials training and individualized career development to post-doctoral clinical and translational scientists via the UT StrokeNet Career Enhancement Program.
What would you say the most significant achievement of the StrokeNet has been? Could you share any key factors that contributed to this success and how it has benefited patients?
Our StrokeNet participation has significantly ramped up clinical trial participation for stroke patients in the Mountain West. We now screen every single stroke patient at University of Utah hospital and stroke clinics for eligibility in clinical research. Between 2018 and 2022, approximately 25% of our hospitalized ischemic stroke patients agreed to participate in clinical research—a phenomenal achievement, unmatched by most institutions. This means that if you come to UUH with stroke, you're not only being seen by the region's best stroke neurologists, but you are also being offered the nation's best clinical trials. In addition, because we have created a robust network in our region, many of our partner hospitals are also able to offer the same clinical trials to their patients.
