Translating Clinical Research into Improved Stroke Patient Care
Clinical research at University Hospitals Neurological Institute’s Comprehensive Stroke Center in Cleveland, Ohio, is aimed at quickly translating basic science directly into improved patient care. Care at the Comprehensive Stroke Center is always shaped by the most innovative medical and surgical therapies because our experts continuously engage in research. Our affiliation with Case Western Reserve University School of Medicine allows basic science research to be quickly translated to findings that will improve patient care. Over the past several years, the Comprehensive Stroke Center has secured over $2 million in clinical research funding, the majority of it coming from the National Institutes of Health (NIH).
Understanding Clinical Trials
Clinical trials are research studies that involve the participation of human volunteers. The purpose of a clinical trial is to test the safety and effectiveness of new ways to diagnose, prevent and treat a medical problem, such as disease, illness or injury.
Being part of a clinical trial can be a chance for patients to receive new or additional treatment. While research may not always have a direct benefit to the participant, clinical trials can help scientists and doctors to learn and understand the better ways to help treat their patients and patients in the future.
Current Clinical Trials
- StrokeNET: The StrokeNet grant is a new way of operating and conducting collaborative clinical NIH trials across the country. Cleveland has been chosen as a Regional Coordinating Center, which is comprised of the four major health care institutions (Cleveland Clinic, MetroHealth Medical Center, University Hospitals, and the Louis Stokes Cleveland VA Medical Center) along with its satellite hospital systems to conduct NIH stroke and neurology research. What makes this unique is that all four institutions and its corresponding satellite hospitals will operate and conduct clinical research trials under one financial budget and contract and utilize one central IRB. This will allow for us to maximize efficiencies in the development, promotion and conduct of multi-site exploratory phase I, II and confirmatory phase III clinical trials in stroke prevention, treatment and recovery that are funded by NIH.
- ACTISSIMA: This is a controlled study evaluating the stereotactic or minimally invasive injection of SB623 stem cells into the brain of patients with paralysis from a prior ischemic stroke. (Surgical site only – for referrals from recruiting sites).
- CREST-2 | CREST-2 Registry: This study is actually two independent multicenter, randomized controlled trials of carotid revascularization and intensive medical management versus medical management alone in patients with asymptomatic high-grade carotid stenosis. One trial will focus on carotid repair with carotid endarterectomy and the other will focus on carotid stenting. Aggressive medical management to control vascular risk factors will be uniform for all the treatment groups and will be centrally directed.
- DAWN: This clinical trial will evaluate the use of mechanical thrombectomy in carefully selected patients with acute stroke of 6-24 hours duration. The hypothesis is that mechanical revascularization of an occluded intracranial artery using the Trevo thrombectomy device, along with medical management, leads to superior clinical outcomes at 90 days as compared to medical management alone.
- EDGE NEWTON: This multicenter, randomized trial is studying the efficacy and safety of EG-1962 versus the current standard of care with Nimodipine in Adults with Aneurysmal Subarachnoid Hemorrhage.
- iDEF The purpose of this study is to determine whether treatment with the iron chelator, Deferoxamine Mesylate, improves the outcome of patients who have had an intracerebral hemorrhage.
- NAVIGATE-ESUS: This is a study in patients who recently had a brain attack (stroke) and in whom no clear cause of the stroke could be identified (embolic stroke of undetermined source, or ESUS). The study will compare two blood thinners – Rivaroxaban 15 mg or Aspirin 100 mg – to determine which is better in preventing further blood clots in the brain (stroke) or in other blood vessels.
- Roadster-2: This study will evaluate real world usage of the ENROUTE Transcarotid Stent and Transcarotid Neuroprotection System in the management of carotid artery disease.
- Surgical Theater for Acute Stroke Surgical Therapy: The Surgical Rehearsal Platform allows for pre-operative rehearsal of a planned aneurysm surgery on a computer work station using the patient’s own imaging. The objective of this clinical study is to determine if the use of the Surgery Rehearsal Platform SRP will lead to improved effort and time efficiency in cerebral aneurysm surgery.
- SystemCHANGE: This randomized controlled pilot study will examine the efficacy, feasibility and safety of a health promotion and wellness program in stroke survivors.
- TeleRehab: This study will test the effectiveness of a novel home-based telehealth system designed to improve motor recovery and patient education after stroke.
Completed Clinical Trials
- MultiStem Therapy for Stroke: The purpose of this industry-sponsored study is to determine the safety and efficacy of MultiStem (stem cell therapy) in patients with ischemic stroke within 24-36 hours.
- Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH-II): The purpose of this NIH-funded study is to determine which of two blood pressure targets is superior in reducing hematoma expansion and improving outcomes after acute intracerebral hemorrhage. Stenting & Angioplasty with Protection in Patients at High Risk for Endarterectomy – Sapphire Registry This industry sponsored registry will determine risks of major adverse events in the treatment of carotid occlusive disease with the Cordis PRECISE® Nitinol Stent System and Cordis ANGIOGUARD™ XP/RX Emboli Capture Guidewire.
- Carotid Revascularization with ev3 Arterial Technology Evolution (CREATE): This industry-sponsored registry will evaluate the efficacy and safety of the ev3's Protege(R) Nitinol Self-Expanding Stent with the company's SPIDER(TM) Embolic Protection Device in the treatment of carotid occlusive disease.
- CLEAR lll: This study is a multicenter, international, double-blind, randomized study comparing the use of EVD combined with rt-PA against EVD combined with placebo for the treatment of intraventricular hemorrhage.
- Stenting vs. Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS): NIH-funded study is to compare the safety and effectiveness of intensive medical therapy plus stenting versus intensive medical therapy only in preventing stroke, heart attacks or death.
- Insulin Resistance Intervention After Stroke Trial (IRIS): The purpose of this NIH-funded study is to determine if pioglitazone is effective in preventing future strokes or heart attacks among non-diabetic persons who have had a recent ischemic stroke.
- Secondary Prevention of Small Subcortical Strokes Trial (SPS3): The goal of this NIH-funded study is to learn if combination antiplatelet therapy (aspirin and clopidogrel) is more effective than aspirin alone for the prevention of recurrent stroke and cognitive decline, and if intensive blood pressure control is associated with fewer recurrent strokes and cognitive decline.
- PFO Closure in Cryptogenic Stroke (RESPECT): The goal of this industry-sponsored study determines if PFO closure with the AMPLATZER PFO Occluder was superior to the current medical standard of care in the prevention or recurrent embolic stroke in patients with a cryptogenic stroke due to presumed paradoxical embolism.
- Targeted Management Intervention for African-American Men with TIA or Stroke (TEAM): This goal of this NIH-funded study is to determine barriers and facilitators to post-stroke care with the purpose of developing a behavioral intervention to improve adherence with preventive therapies. Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage (CLEAR-III) This goal of this NIH-funded study is to determine if intraventricular tPA is superior to the current standard of care in the resolution of intraventricular hemorrhage and improving outcomes after hemorrhagic stroke.
- Minimally Invasive Surgery plus rt=PA for Intracerebral Hemorrhage Evaluation (MISTIE-ICES): The purpose of this NIH-funded study is to determine if minimally invasive hematoma evacuation is superior to the current medical standard of care in improving outcomes after hemorrhagic stroke. “Non-invasive Brain-Signal Training to Induce Motor Control Recovery After Stroke” Janis J. Daly, PhD, associate professor of neurology at Case Western Reserve University School of Medicine, was awarded a $1 million EUREKA grant from the National Institutes of Health (NIH) to investigate the feasibility of using Electroencephalography (EEG) signals to direct brain retraining following stroke.
- Interventional Management of Stroke (IMS) III Trial (IMS III): The purpose of this NIH-funded study was to compare two different treatment approaches—combined intravenous and intra-arterial recombinant tissue plasminogen activator (rt-PA) and standard intravenous (IV) rt-PA—to restoring blood flow to the brain.
- Carotid Occlusion Surgery Study (COSS): The purpose of this NIH-funded study was to determine if extracranial-intracranial bypass surgery, when added to best medical therapy can reduce the subsequent risk of ipsilateral stroke in high-risk patients with recently symptomatic carotid occlusion and increased cerebral oxygen extraction fraction measured by PET.
- Clazosentan in Reducing Vasospasm-Related Morbidity and All-Cause Mortality in Adult Patients With Aneurysmal Subarachnoid Hemorrhage Treated by Surgical Clipping (CONSCIOUS-2):The aim of this industry-sponsored study was to demonstrate that clazosentan, administered as a continuous intravenous infusion at 5 mg/h until Day 14 post aneurysmal subarachnoid hemorrhage (aSAH), reduces the incidence of cerebral vasospasm-related morbidity and all-cause mortality within 6 weeks post-aSAH treated by surgical clipping.
- Clinical Outcome in Acute Stroke Treatment After Image Guided Patient Selection for Interventional Revascularization Therapy (START): This industry-sponsored study was designed to assess the safety and effectiveness of the Penumbra System in a stroke cohort with a known core infarct volume derived from imaging at admission.