Advances in cardiothoracic disease treatments are made by surgeons willing to push the limits of current medicine through clinical trials. At Montefiore-Einstein Heart Center, surgeons are not only asking what's possible, they're among the only heart centers in the world launching clinical research to find out.
Montefiore-Einstein has an active clinical research program that includes both government and industry-sponsored protocols, and trials that are initiated within Montefiore-Einstein. Current clinical trials include:
The STICH trial is an international clinical trial sponsored by the National Heart, Lung, and Blood Institute (NHLBI) studying the effectiveness of treatments for coronary artery disease and heart failure. The trial asks the question: are patients better served with medicine, bypass surgery, or a combination of bypass and surgical ventricular reconstruction, a procedure that reshapes the heart to a more normal size? Currently, Cardiothoracic Surgery Department Chairman Dr. Robert Michler is the chairman of the Surgical Therapy Committee for the STICH trial.
Montefiore-Einstein is involved in clinical trials that are following the progress of patients, particularly patients with Marfan syndrome, who receive valve-sparing surgery to determine the long term benefits of the procedure. Dr. Abe DeAnda leads this trial.
Mechanical heart devices
Montefiore-Einstein is involved with several clinical trials to investigate the use of the small ventricular assist devices (VAD) or heart pumps. Clinical research is evaluating these devices as bridge to transplant therapies used to support heart function during the wait for a suitable transplant match. They're also testing the use of these new devices as an alternative to transplant. Dr. Daniel Goldstein leads this trial.
Montefiore-Einstein is leading the nation in the study of whether it's possible for severely damaged heart muscle to regenerate. Their studies ask three investigative questions:
Can skeletal muscle cells from the patient's own thigh stimulate the regeneration of heart muscle tissue?
Doctor Robert Michler, the Chairman of the Department of Cardiothoracic Surgery, is a lead author on a paper published in Circulation that proved skeletal muscle is safe for implantation into the heart muscle.
Can stem cells harvested from the patient's own heart muscle be used to stimulate heart muscle regeneration?
Montefiore-Einstein has an exclusive research partnership with Dr. Piero Anversa, the world's foremost authority on cardiac stem sells, to study the properties of cardiac stem cells in order to help direct future treatment efforts.
Can stem cells harvested from the patient's own bone marrow be injected into the heart to stimulate heart muscle regeneration?
Montefiore-Einstein is among a handful of centers worldwide under consideration to host a clinical trial sponsored by the National Institutes of Health (NIH) and NHLBI to inject a patient's bone marrow stem cells into the heart at the time a patient receives a mechanical heart as a method of repairing damaged tissue.
Because Montefiore-Einstein understands that innovation is made through questioning and testing, they are continuously applying for additional clinical trials. Currently, Montefiore-Einstein has a pending application for a network grant from the NHLBI. The NHLBI will select seven sites from around the US to conduct major clinical trials on the major questions in the field of cardiovascular medicine and surgery.
By devoting study to such possibilities, Montefiore hopes to turn today's hypothetical therapies into the gold standard of tomorrow's care.