Project Title Intermountain Pediatric Heart Disease Research Center

Principal Investigator & Institution: Minich, L L. Pediatrics; University of Utah 200 S University St Salt Lake City, UT 84112

Summary: (provided by applicant) Heart disease is a leading cause of morbidity and mortality in children. A network of research centers with both a sufficient clinical population and team of researchers trained to conduct multi-center trials could provide standardized, blinded, quality research that has the statistical power to change the way children with heart disease are managed. Primary Children?s Medical Center, located in Salt Lake City, Utah, is uniquely qualified to participate as a research center within such a network. It serves as the leading referral hospital for children with heart disease in the Intermountain West. The overall goal of the proposed Intermountain Pediatric Heart Disease Research Center is to collaborate in prospective, randomized, multi-institutional trials that provide robust data leading to the advancement of knowledge regarding pediatric heart disease and evidence-based pediatric medicine. The specific aims of the Intermountain Pediatric Heart Disease Research Center are: to propose scientifically sound, statistically robust research protocols that can be performed within the Pediatric Heart Disease Clinical Research Network; to enroll eligible children at Primary Children?s Medical Center; and to collect complete data and readily communicate results within the Pediatric Heart Disease Clinical Research Network so as to facilitate the rapid dissemination of research findings. We propose two clinical studies for the Pediatric Heart Disease Clinical Research Network. The overall goal of protocol 1, "Efficacy of Abciximab in Treating Children with Large Coronary Aneurysms," is to compare the effectiveness of abciximab added to conventional therapy versus conventional treatment alone for dissolving or preventing thrombi and for facilitating remodeling in large coronary artery aneurysms attributed to Kawasaki disease, The overall goal of protocol 2, "Decellularized Human Allograft Valve Preparation (Cryovalve SGR) versus Standard Cryopreserved Valved Allografts for Vascular Reconstruction in Children," is to determine the function and long-term durability of decellularized human allograft valve preparation versus the current state-of-the- art cryopreserved valved allograft. The investigators agree to enthusiastically participate in and diligently adhere to any protocol selected by the Pediatric Heart Disease Clinical Research Network. The applicant organization, Primary Children?s Medical Center, agrees to the per patient capitation of operational costs for the study protocols selected by the Pediatric Heart Disease Clinical Research Network.

Website: http://crisp.cit.nih.gov/ crisp/Crisp_Query.Generate_Screen

• Project Title: ISCHEMIA/REPERFUSION INJURY IN DIABETIC HEART

Principal Investigator & Institution: Mcdonagh, Paul F. Professor; Surgery; University of Arizona P O Box 3308 Tucson, AZ 857223308

Timing: Fiscal Year 2001; Project Start 01-AUG-1997; Project End 31-JUL-2003

Summary: Diabetes is now considered a prime risk actor for cardiovascular disease, particularly ischemic heart disease. The risks for myocardial infarction, reinfarction, ischemic heart failure, stroke and the associated mortalities are all significantly increased in diabetes. The pathobiology underlying the excessive and severe ischemic heart disease in diabetes is unclear. Myocardial ischemia-reperfusion (I'R)injury involves both early and late phases. In the early phase, the initial deposition of leukocytes amplifies cardiac injury via an acute inflammatory response. The initial step in acute inflammation is leukocyte, particularly PMN, deposition in the coronary microcirculation. It is not clear how PMNs initially accumulate in the microcirculation, but recent studies suggest that this step is amplified in the diabetic heart following ischemia. Once accumulated, the PMNs activate and produce oxygen free radicals, causing further damage to the vasculature and myocytes. Following ischemia, if PMN deposition is excessive in the diabetic coronary microcirculation an(LIor if diabetic

PMNs are hyper-responsive to cytokines released from ischemic tissue, then the severity of leukocytemediated reperfusion injury may be excessive as well. In this project, we will test the hypothesis that diabetes causes alterations in both the blood and the coronary blood vessels. These alterations set the stage for an excessive leukocyte-mediated reperfusion injury in the diabetic heart. If so, then pharmacologically blocking early PMN-mediated inflammation will reduce reperfusion injury and improve the recovery of myocardial contractile function. We will first investigate specific mechanisms, suspected to cause the excessive blood-coronary microvessel interactions observed in diabetes. We will then compare leukocyte adhesion protein characteristics and the "reactivity" of PMNs to stimulation in Type I and Type II diabetic animals and in patients with Type II diabetes. We will determine if platelets and plasma complement, modulate leukocyte function and leukocyte reactivity in diabetes. The therapeutic potential of limiting leukocyte-mediated inflammation in diabetes will be evaluated. Those pharmacologic agents and antibodies that prove to attenuate the early PMN-mediated response will be tested for efficacy to improve the recovery of myocardial contractile function in the diabetic. The lessons learned from these studies will aid in developing improved therapies to reduce the excessive ischemic heart disease observed in diabetes.

Website: http://crisp.cit.nih.gov/ crisp/Crisp_Query.Generate_Screen

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