As Director of the EECP Research Lab, Dr. Soran and her colleagues have recognized that EECP is safe and effective in patients with ischemic heart disease and compromised left ventricular function (J Cardiac Failure). This important observation led them to undertake a safety and efficacy study of EECP in patients with both ischemic and non-ischemic left ventricular dysfunction and heart failure (Congestive Heart Failure). Not only did EECP appear to improve outcomes in patients with both ischemic and non-ischemic myopathies, but also the benefits appeared to be persistent for up to 6 months after therapy. These findings lead the FDA to approve the use of EECP treatment in heart failure management on June 2002.
Based on these salutary effects of EECP in patients with left ventricular dysfunction, a multi-center clinical study, the PEECH Trial, (Prospective Evaluation of Enhanced External Counterpulsation (EECP) was begun in 2001. Dr. Soran is serving as a Principal Investigator for this study. The results of this study are expected to be published in 2006.
Dr. Soran also serves as the primary investigator of International EECP Patient Registry (IEPR) and have been instrumental in organizing the International EECP Patient Registry with the Graduate School of Public Health Epidemiology data center. Currently, 5000 patients from over 90 centers are enrolled in this phase- I Registry. Additional 2500 patients have been enrolled to the phase-II. By using IEPR data, several publications have been made to fill the gaps that have not been answered by clinical trilas.
Observation from this EECP registry is the beneficial effects of EECP in patients with coronary disease appear to perist for up to 1 year after treatment. This observation led her and her colleagues from across the country to hypothesize that the most likely mechanism for EECP's benefits was the development of collateral vessels in response to EECP-induced shear stress in the coronary arteries.
To test this hypothesis, Dr. Soran has participated in a pilot study with a group of highly prestigious investigators including Dr. George Beller, Chief of the Division of Cardiology at the University of Virginia, Dr. Anthony DeMaria, Chief of the Division of Cardiology at UCSD, and Dr. Richard Conti, Emeritus Chief of the Division of Cardiology at the University of Florida. Using state of the art imaging technology, they have obtained pilot data assessing the development of new vascular beds in the coronary circulation after EECP. If the final results support the initial hypothesis, this data will be used to support the submission of a NIH grant application.
Dr. Soran has received a $2.8M grant from the Centers for Medicare and Medicaid Services (CMS) to conduct a 4-year study assessing the impact of the Alere Heart Failure monitoring system on clinical outcomes and the economics of care among Medicare beneficiaries representing underserved population including women and non-Caucasian men. Unique aspects of this project are that Medicare beneficiaries who are diagnosed with heart failure are being enrolled from a group of community-based primary care practices rather than University affiliated teaching hospitals. The study institutes an educational program for both physicians and patients to improve compliance with recent HFSA, AHA and ACC guidelines for heart failure and evaluates a group of heart failure patients that make up a major portion of the Medicare population who are largely ignored in most heart failure trials (i.e. women and non-Caucasian males). Enrollment began on April 2002.
Patients are being enrolled from three sites: The University of Pittsburgh, Case Western University, and the Mount Sinai Medical Center. Being the Primary Investigator for the Pittsburgh site and the director of the previously mentioned study sites allows the University of Pittsburgh/UPMC to play a pivotal role in this Medicare funded project.