New Washington Hospital Center Clinical Study Uses Rheologics Device to Collect Blood Viscosity Data on Hypertensive and High Cholesterol Patients.Business Editors/Health and Medical Writers EXTON, Penn.--(BW HealthWire)--March 12, 2002 The Kensey Rheolog(TM) Will Measure Patient Blood Viscosity Throughout the 18-Month Double Blind, Randomized Clinical Trial randomized clinical trial, n a clinical study where volunteer participants with comparable characteristics are randomly assigned to different test groups to compare the efficacy of therapies. of an FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. Approved Medication Rheologics, Inc., a pioneer in the prevention and treatment of heart disease and stroke, today announced that its Kensey Rheolog(TM), the first point-of-care device to more accurately measure blood viscosity, is being used in conjunction with a clinical study initiated last month at Washington Hospital Center Washington Hospital Center Washington Hospital Center is the largest private hospital in Washington, D.C.. A member of MedStar Health, the not-for-profit Hospital Center is licensed for 926 beds and, on average, operates near capacity. in Washington, DC. Julio A. Panza, M.D., the director of the hospital's coronary care unit coronary care unit n. Abbr. CCU A hospital unit that is specially equipped to treat and monitor patients with serious heart conditions, such as coronary thrombosis. is the study's principal investigator. Umberto Campia, M.D., senior research fellow at MedStar Research Institute is the trial's co-investigator. Over an 18-month period, the study will measure and compare changes in brachial artery brachial artery n. 1. An artery that is a continuation of the axillary artery, with branches to the deep brachial, superior and inferior ulnar collateral, muscular, and nutrient arteries, and with bifurcations at the elbow into the radial and reactivity, forearm blood flow and blood viscosity in 100 hypertensive hypertensive /hy·per·ten·sive/ (-ten´siv) 1. characterized by increased tension or pressure. 2. an agent that causes hypertension. 3. a person with hypertension. or hypercholesterolemic patients taking an FDA approved medication or a placebo during eight-week periods. "Patients with high blood pressure or high cholesterol Cholesterol, High Definition Cholesterol is a fatty substance found in animal tissue and is an important component to the human body. It is manufactured in the liver and carried throughout the body in the bloodstream. frequently experience significant blood vessel damage over time," Dr. Panza noted. "This study is examining the effect of a new treatment that may decrease that risk. By incorporating the use of the Kensey Rheolog into the study, we can draw additional data points on the effect of the medication on blood viscosity, another potential indicator of a patient's level of vascular damage and the corresponding risk of arterial or heart disease." Dr. Panza added that three staff members were trained on the use of the Kensey Rheolog prior to the study's initiation. "The device is easy to use and is the only equipment on the market that can give us quick analysis of viscosity along a broad range of shear rates on unadulterated un·a·dul·ter·at·ed adj. 1. Not mingled or diluted with extraneous matter; pure. See Synonyms at pure. 2. Out-and-out; utter: the unadulterated truth. blood samples." One hundred patients between the ages of 18 and 65 - half with hypertension and half with hypercholesterolemia Hypercholesterolemia Definition Hypercholesterolemia refers to levels of cholesterol in the blood that are higher than normal. Description Cholesterol circulates in the blood stream. It is an essential molecule for the human body. - are scheduled to participate in the double blind, placebo controlled, randomized clinical trial. For hypertensive patients, cholesterol levels must be less than 200; high cholesterol patients must have levels between 240-400 and a blood pressure below 140/90. Investigators hope to present the data from this study in late 2003. About the Kensey Rheolog(TM) The Kensey Rheolog(1) is the culmination of more than 12 years of collaborative study of the biophysical properties of blood by the Rheologics executive management team, led by founder and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. Kenneth R. Kensey, M.D. It is the industry's first point-of-care device to more accurately measure blood viscosity by enabling healthcare providers and researchers to test circulating, unadulterated blood. By using advanced microprocessors, proprietary biocompatible materials and algorithms, the Kensey Rheolog captures a patient's continuous blood viscosity over a broad range of shear rates in an environment that mimics the human artery. This allows for an accurate and unadulterated blood viscosity reading in just under five minutes. About Rheologics, Inc. Since 1997, Rheologics Inc. has pioneered a new standard of care in the prevention and treatment of heart disease and stroke. Supplementing the existing understanding of the risk factors for these diseases, Rheologics' mission is to complete the picture by focusing on the emerging field of hemorrheology - the study of the dynamics of blood flow and its impact on vascular-related diseases. Rheologics is headquartered in Exton, Pennsylvania. For more information, please call 1-800-969-2585 or visit the company web site at www.rheologics.com. Note (1): The Kensey Rheolog is an IDE exempt device and is not approved by the FDA for therapeutic and diagnostic use. The device is currently used by leading institutions for research purposes. |
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