The most recent project, centered in the International Center for Health Outcomes and Innovation Research (InCHOIR), a joint initiative of the Mailman School and the Department of Surgery, received a $23 million grant in July from the National Heart, Lung, and Blood Institute to act as the Data Coordinating Center for a newly established Cardiothoracic Surgery Investigations Network.
Trials conducted in the network’s seven clinical centers in the United States and Canada will help answer key questions about which cardiac surgeries are most beneficial for which patients and when new technologies may or may not be appropriate.
“Cardiac surgery is one of the most rapidly evolving fields of medicine; however, new procedures and devices are often adopted without a thorough evaluation of their benefits, particularly with regard to established therapies,” says Michael Parides, Ph.D., associate clinical professor of biostatistics at Mailman and principal investigator of the Data Coordinating Center.
As data coordinating center, InCHOIR will be responsible for the trial design and protocol development, clinical coordination, data review and management, and monitoring of the network’s clinical sites, including one at NewYork-Presbyterian Hospital/ Columbia.
“The expertise we have at InCHOIR allows us to rigorously and efficiently assess the value of new technologies and therapies, ensuring their quick translation into practice when appropriate,” Dr. Parides says. InCHOIR members Annetine Gelijns, Ph.D., professor of health policy & management and surgical science (in surgery); Alan Moskowitz, M.D., associate professor of clinical medicine and clinical health policy & management (in surgery); and Deborah Ascheim, M.D., assistant professor of medicine and health policy & management, round out the leadership team of the Data Coordinating Center.
Within P&S, a $1.5 million grant from the Jerome L. Greene Foundation has been used to launch the Cardiac Valve Program in the Department of Medicine. Led by Linda Gillam, M.D., a leader in cardiology and echocardiography who was recently recruited from the University of Connecticut, the new program will integrate noninvasive, interventional, and surgical management options for patients with valvular heart disease within a robust clinical research enterprise.
“The intent in building the program is not to start from scratch, but to integrate all the elements that are already here superb clinical cardiologists, innovative interventionalists and internationally recognized surgeons to make it easier for patients to access treatment. At the same time we are creating a structure for clinical and basic science research,” Dr. Gillam says.
The new cardiac valve center is one of only a few coordinated programs in the nation to focus on valvular disease, a condition that remains understudied despite its prevalence and high rates of mortality and morbidity. About 8 percent of 65- to 74-year-olds and 13 percent of those over age 75 have valve disease, and some valve conditions increase the risk of death from a heart attack.
The new program will operate a registry that will capture all clinical and procedural data on Columbia patients with valvular disease. “Registries of hundreds of thousands of patients with coronary disease have allowed us to study the epidemiology of that disease and evaluate new treatments, but there are no such registries for patients with valve disease,” says Dr. Gillam. “That will be a very important starting point for us.”
Dr. Gillam also anticipates collaborating with other schools on research involving valve disease and dental procedures. “Despite the fact that it has been recommended for many years that patients with valve disease get antibiotics at the time of dental procedures to prevent endocarditis, there is no support that it is beneficial,” she says. “My colleague, Rebecca Hahn, M.D., [assistant professor of clinical medicine] and I have just submitted a proposal with our colleagues in dentistry and public health to identify more rigorously the risk factors for endocarditis.”
Another collaborative research project involving the College of Dental Medicine, P&S, and Mailman focuses on the effects of periodontitis treatment on atherosclerosis. Led by Panos N. Papapanou, D.D.S., Ph.D., chairman of the Section of Oral and Diagnostic Sciences at the College of Dental Medicine, the study will identify mechanisms that link periodontal status, systemic inflammation and atherosclerosis.
In a collaboration between the School of Nursing and P&S, assistant professor of nursing Kathleen Hickey, Ed.D., is working with director of clinical cardiac electrophysiology Hasan Garan, M.D., to coordinate all of the division’s electrophysiology research. With a pilot grant from the National Institute of Nursing Research, Dr. Hickey will study atrial fibrillation in the elderly. Patients in the study, who have significant risk factors for atrial fibrillation but no documented history of the condition, will be monitored at home for two weeks in an attempt to document silent arrhythmias, a condition that significantly raises the risk of stroke if undetected.