In a new clinical study beginning at the University of Pittsburgh Medical Center (UPMC) and Baylor University Hospital, cardiologists are treating congestive heart failure with a genetically engineered protein to “mop up” and control a naturally occurring compound, called TNF-alpha, that causes inflammation and heart damage.  
This “mopping up” prevents TNF-alpha from impacting on heart tissue and may lead to an improvement in some of the symptoms of congestive heart failure patients.  
The protein, called TNFR:Fc, inhibits the activity of TNF-alpha. People with congestive heart failure have elevated levels of TNF-alpha, and it has been suggested that TNF-alpha may play a role in the development of heart failure, according to Arthur Feldman, M.D., Harry S. Tack professor of medicine, chief of cardiology at UPMC Presbyterian and professor of cell biology and physiology.  
“TNF-alpha can produce dysfunction of the heart, heart remodeling, pulmonary edema and cardiomyopathy,” Dr. Feldman said. “It is known to be produced by the failing heart but not by the non-failing heart. In our Cardiovascular Research Center, we developed transgenic mice with overexpressed TNF-alpha. They subsequently developed severe myocarditis or inflammation of the heart.”  
In an earlier preliminary clinical trial carried out in Houston by Douglas Mann, M.D., professor of medicine, Baylor College of Medicine and principal investigator of the current study, patients with congestive heart failure who received a single injection of TNFR:Fc were able to walk father and felt better than before therapy. There also was an improvement in the heart's ability to pump blood.  
“Current therapies for congestive heart failure are less than adequate,” said Dr. Feldman, principal investigator at  UPMC. “This is the first time a genetically engineered, specifically targeted drug has been developed for congestive heart failure. This trial will investigate whether we can use this therapy safely in congestive heart failure and whether we can improve heart function and the quality of life of our heart failure patients”.  
An estimated 4.8 million Americans have congestive heart failure, in which the heart cannot maintain adequate circulation of the blood because it fails to pump blood properly. It is the chief cause of about 40,000 deaths in the United States each year and is a major contributing factor in an additional 225,000 deaths.  
The randomized, placebo-controlled Phase I  trial will enroll approximately 45 patients.  
The patients will be divided into three groups: two groups will receive TNFR:Fc and the third will receive a placebo. Each patient will receive the study medication through an injection, twice a week for three months, after which all patients will be evaluated.  
TNFR:Fc is an investigative product developed and manufactured by Immunex Corporation, a biopharmaceutical company of Seattle, under the trademark Encrel.® Enbrel, a genetically engineered, soluble receptor, is a biologic inflammation modulator. It acts as a competitive inhibitor of the bonding of TNF-alpha to its cell surface receptors and thereby inhibiting TNF biological activity.  
The study is being conducted in conjunction with Baylor College of Medicine and Immunex Corporation.  
For additional information about UPMC Health System, please access: http://www.upmc.edu.  
   

UPMC's image engine project expands medical records system  

Medical records have entered the realm of the electronic world through the University of Pittsburgh Medical Center's (UPMC) Image Engine Project, a multimedia electronic medical record system that combines clinical images with textual data stored in UPMC's Medical Archival Record System (MARS). It is a research effort designed to develop an integrated multimedia view of the electronic medical record.  
Funded by the U.S. National Library of Medicine's High Performance Computing and Communications and National Telemedicine Initiatives programs, the project began in 1994 and is based at the University of Pittsburgh's Clinical Multimedia Laboratory (CML) in the Center for Biomedical Informatics. It is directed by Henry Lowe, M.D., associate professor of medicine, and director of CML. According to Dr. Lowe, most, if not all, existing computer medical records systems store only text. But increasingly, medicine has become very image intensive, and clinical images have become an important part of a patient's medical records.  
“This is a problem”, Dr. Lowe said. “In most computer-based medical records systems, images simply can't be stored in the system - instead “hard copy” files that undermine the speed and ease of a computerized system are needed to store these vital pieces of information”.  
The Image Engine system, however, nay ameliorate this problem. This type of computer system can store and retrieve visual images much the same way that traditional systems store text. Ideally, an image engine would not only be able to pull up a clinical image by patient name and type of image, but also by type of disease, stage of disease, and even specified visual elements present in the image.The system allows clinicians to download a series to thumbnail images on the screen which are u sed to help the physician select which full-size images to retrieve for viewing. Currently, the system can acquire, compress, store, retrieve, display and manipulate many kinds of clinical images, including radiographs, CT scans, MRI scans, nuclear medicine studies, gastrointestinal endoscopy images, EKGs and microscopic pathology. Through the collaboration of project technologists and medical records specialists at the University of Pittsburgh Cancer Institute (UPCI), a complete multimedia medical records system has been established for about 600 patients seen at UPCI.  
“For now, Image Engine is being evaluated in the oncology setting,” Dr. Lowe said. “We are looking to expand into other clinical area in the future.”  
“We can retrieve clinical images easily and use them to inform patients about the progress of their treatments or show them responses of tumors to alternative tests they may  wish to try,” said Ted Logan, M.D., assistant professor of medicine, medical oncologist at UPCI and collaborator on the Image Engine Project. “All of this is done while maintaining patient confidentiality.”  
“We can reuse images in the clinical system for teaching,” Dr. Lowe explained. Designing the system to retrieve  medical images without patient identification information helps expose medical students to the subtleties on imaged as they are obtained in real practice, while maintaining strict patient confidentiality. Additionally, a researcher could scan a hospital's records for patients with a medical condition being studied and correlate that condition whit any number of diagnostic or treatment results.  
Dr. Lowe explained that while the system is very secure, as it requires logons and passwords at every session and is firewalled and isolated from the Internet, ensuring patient confidentiality in a variety of situation is a challenge. “Another part of the project is aimed at making data available in a very secure fashion,” he explained. “We're designing the system to provide very secure access to authorized users from anywhere in the world.” In effect, clinicians would be able to consult through use of the Image Engine by simply taking a particular image and sending it trhough e-mail. This could be useful, according to Dr. Lowe, in situations where patients are seen by physicians in emergency situations while traveling out of state. Internet access could also facilitate collaborative research projects or telemedicine initiatives.Recently, the Image Engine Project was awarded semi-finalist status in the Global Information Infrastructure (GII) Awards Program. The GII Awards recognized champions from all industries and sectors of society who use the Internet and network technology to produce amazing results.  
“The Image Engine Project's achievement demonstrate that the Internet can lead to a society that is healthier, better educated and more prosperous,” said Jamed Hake, GII Awards chairman and founder. “As a GII semi-finalist, the Image Engine Project has been distinguished for innovation, producing real and valuable results and powerfully demonstrating the potential of the Internet.”  
For additional information about the Image Engine Project, please access http://www.cml.upmc.edu. For additional information about UPMC Health System, please access http://www.upmc.edu.