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Stroke and Neurovascular Program
Clinical ResearchClinical trials (also called medical research and research studies) help establish the safety and effectiveness of new drugs, medical devices or therapies as well as new ways of using current treatments. Each trial is designed to answer specific questions and to find better ways to treat people who have suffered a stroke.
Stroke clinical trials conducted at Froedtert & the Medical College of Wisconsin include:
Acute Stroke Research Projects
- Study of Acute Viprinex (Ancrod) for Emergency Stroke in Patients Beginning Treatment within 6 Hours of the Onset of Acute, Ischemic Stroke (Ancrod Trial) — this study is evaluating the effectiveness, safety and tolerability of Ancrod, an investigational drug that is derived from snake venom. Ancrod acts to reduce fibrinogen in the blood, which reduces clotting and also improves blood flow within and to the brain. This study is being conducted internationally at about 150 hospitals. Michel Torbey, MD, MPH, FAHA, is the principle investigator at Froedtert & the Medical College of Wisconsin.
- Safety and Efficacy of NeuroFlo Treatment for Ischemic Stroke (SENTIS Trial) — this trial is investigating the augmentation of cerebral perfusion in patients with acute ischemic stroke who are not eligible for treatment with tPA, using an intra-aortic balloon within eight hours of stroke onset. The NeuroFlo balloon catheter works by increasing blood flow to the brain through restriction of blood flow in the descending aorta (the part of the aorta that runs down through the chest and the abdomen). The catheter is inserted in an artery in the thigh and advanced to the abdominal aorta (the section of the aorta that begins at the diaphragm and runs down to the two leg arteries). This may become an important treatment option for patients who arrive for care beyond the time limit for delivering current therapies. This study is being conducted at more than 40 sites in the United States. Michel Torbey, MD, MPH, FAHA, is the principle investigator at Froedtert & the Medical College of Wisconsin.
- Interventional Management of Stroke (IMS III) Trial — this multi-center study of the National Institutes of Health is for patients within three hours of symptom onset of an acute ischemic stroke. The study is comparing treatment with intravenous tissue plasminogen activator (IV tPA, the standard FDA approved treatment) to a combination of IV tPA plus intra-arterial tPA administered via a small catheter directly into the blocked artery within the brain. Froedtert & the Medical College of Wisconsin have the only program in Wisconsin participating in this study. Osama Zaidat, MD, MSc, is the principle investigator at Froedtert & the Medical College.
- Albumin in Acute Stroke Trial: A Trial of High-Dose Albumin Therapy for Neuroprotection in Acute Ischemic Stroke (ALIAS Trial) — this study is to evaluate the effectiveness of high-dose, intravenous human serum albumin in the treatment of ischemic stroke within 5 hours of stroke onset. In animal laboratory studies, it has been shown to reduce the size of infarction in the brain and improve neurological function after stroke, and also decrease or eliminate brain swelling that may occur. About 60 sites will enroll participants worldwide. Michel Torbey, MD, MPH, FAHA, is the principle investigator at Froedtert & the Medical College of Wisconsin.
- Hyperbaric Oxygen Therapy of Acute Ischemic Stroke (HOTS Trial) — this study is evaluating the safety of hyperbaric oxygen therapy in the treatment of acute ischemic stroke. Hyperbaric oxygen is the administration of 100 percent oxygen at higher than normal atmospheric pressure. This increases the amount of oxygen circulating in blood and reaching all the parts of the body including the brain. Studies in animals have shown that this can help to reduce the size of a stroke and disability after a stroke by helping to save neurons from dying. Ann Helms, MD, is the principle investigator at Froedtert & the Medical College of Wisconsin.
Genetic Stroke Research Project
- Siblings with Ischemic Stroke (SWISS) — this multi-center study of the National Institutes of Health aims to determine if there is a genetic risk between siblings with ischemic stroke. Researchers are trying to determine if there is a specific gene or gene mutation that links ischemic stroke in siblings. Michel Torbey, MD, MPH, FAHA, is the principle investigator at Froedtert & the Medical College of Wisconsin.
Second Stroke Prevention Research Projects
- Insulin Resistance Intervention after Stroke (IRIS) — this multi-center study of the National Institutes of Health aims at treating patients with insulin resistance in the hope it will help to prevent diabetes and a second ischemic stroke. A medication (approved by the FDA for controlling diabetes) or a placebo is given to patients who have had an ischemic stroke or transient ischemic attack and are insulin resistant. Michel Torbey, MD, MPH, FAHA, is the principle investigator at Froedtert & the Medical College of Wisconsin.
- Secondary Prevention of Small Subcortical Strokes (SPS3) — this study aims to prevent a second stroke in patients who have had a lacunar stroke (a stroke that occurs in the inner part of the brain when small blood vessels become blocked). The study is determining if aspirin and Clopidogrel (Plavix) are better than aspirin alone to prevent a second stroke and if keeping blood pressure low will help to prevent a second stroke. Diane Book, MD, is the principle investigator at Froedtert & the Medical College of Wisconsin.
10-Year Member of the Stroke Member NetworkThe Stroke Member Network is a program of the National Stroke Association that honors member hospitals and stroke teams for their dedication to advancing stroke care. The Stroke and Neurovascular Program at Froedtert & the Medical College of Wisconsin is listed along with only two dozen other hospitals in the country as 10-year members, a tribute to its leadership in advancing knowledge in stroke care.
Quality Care The Stroke and Neurovascular Program consistently measures the quality of care provided to stroke patients, using a variety of measures.
American Heart Association Performance Achievement AwardIn 2006, the Stroke and Neurovascular Program received the performance achievement award (PAA) from the American Heart Association. The performance achievement awards recognize hospitals that demonstrate at least 85 percent compliance in each of the seven core “Get With The GuidelinesSM – Stroke” measures. The annual PAA recognizes performance of 12 consecutive months.
“Get With The Guidelines” is the premier hospital-based quality improvement program for the American Heart Association and American Stroke Association. The program empowers healthcare providers to treat heart and stroke patients according to the most up-to-date guidelines. Primary Stroke Centers comply with these standards of stroke care and report their results.
Stroke Prevention – Free Screenings OfferedFroedtert & the Medical College regularly provide free stroke screenings in collaboration with Small Stones, a health resource center of Froedtert & the Medical College. By assessing people’s medical history, controllable and uncontrollable risk factors, and blood pressure and pulse, we classify their risk for stroke and provide them with an action plan to prevent stroke, including directing people to their physician if they are at a heightened risk. For more information about screening times, call 414-805-3666 or 800-272-3666.
Support and Education
Stroke Support Group The Stroke Support Group allows stroke survivors and their families to exchange ideas and offer encouragement to each other.
A list of other local stroke support groups is available from the American Stroke Association.
Peer Visitor Program In collaboration with the American Stroke Association, the Froedtert & the Medical College of Wisconsin Stroke and Neurovascular Program also sponsors a Peer Visitor Program. Through the program, volunteer stroke survivors attend Stroke Support Group meetings regularly to answer questions and share their personal experiences and successes. The program, facilitated by a psychologist, is designed to help educate and provide wellness for new stroke patients and their families. For more information or to volunteer to be a peer visitor, please call 414-805-3666 or 800-272-3666.
Stroke Prevention Education Froedtert & the Medical College also offer community education programs about stroke prevention. These fulfill the Institute of Medicine’s aim for health care that is patient-centered.
Author: Marla Fraunfelder Last Review Date: Jan. 25, 2008 Online Editor(s): Christopher Sadler
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