Clinical Trials & Research
Cardiothoracic Surgery Clinical Trials: Atrial Fibrillation Ablation During Mitrial Valve Surgery
At the Montefiore Einstein Center for Heart and Vascular Care our surgeons are among the few heart surgery experts nationwide conducting clinical research through the National Institutes of Health Cardiothoracic Surgery Network.
Our surgeons are examining the benefit of atrial fibrillation ablation during mitral valve surgery. Atrial fibrillation is the chaotic irregular beating of the upper chambers of the heart. This condition can lead to strokes and heart failure. Faulty electrical triggers resulting in wavelets of energy that establish an irregular and fast heart rate cause Atrial Fibrillation.
In an effort to help patients suffering from this ailment and to advance cardiac care, we are currently enrolling patients in a clinical trial to eliminate Atrial Fibrillation. Candidates include patients who have mitral valve disease requiring surgery and have persistent atrial fibrillation. Atrial fibrillation ablation can correct the problem, giving patients a better prognosis.
During the ablation procedure, the surgeon places a probe to freeze atrial heart tissue creating a corridor for the passage of an electrical impulse. Ablation lines are very precise, preventing abnormal electrical impulses from passing through. In this way, normal communication of electrical impulses is restored, and the heart rhythm returns to normal.
A multidisciplinary team consisting of cardiologists, electrophysiologists and minimally invasive heart surgeons uses the latest surgical techniques to eliminate atrial fibrillation. By blocking the faulty electrical signals and often removing the atrial appendage where clots form, our surgeons are able to cure this disease in most patients.
For more information, contact Roger Swayze, RN, at 718-920-2221.
Improving Antibiotic Prescribing to Eliminate Clostridium difficile Infection (C. difficile) Through Antimicrobial Stewardardship Collaborative
Many facilities believe that antimicrobial stewardship programs that promote more judicious antibiotic prescribing may decrease overuse of antibiotics in patients getting medical care, which will reduce some negative outcomes including Clostridium difficile Infections (CDI)—a bacterial infection that cause diarrhea, inflammation of the colon or other more severe syndromes, including death.
According to the Centers for Disease Control, CDI is linked to 14,000 American deaths each year, often from commonly prescribed antibiotics. At Albert Einstein College of Medicine, infectious diseases specialist Belinda Ostrowsky, MD, MPH, is leading a wider multi-site collaborative program working with local facilities, hospital associations and national public health agencies to reduce the instance of CDI across a full spectrum of facilities by implementing and studying activities relating to stewardship.
Montefiore Medical Center has initiated a multifaceted interdisciplinary stewardship program to educate, support and advise practicing physicians throughout its extensive network of hospitals, ambulatory care clinics and nursing homes. The program is collaboration between the Departments of Internal Medicine (Division of Infectious Diseases) and the Montefiore Department of Pharmacy. Dr. Ostrowsky and her team of seasoned infectious diseases specialty pharmacists, Yi Guo, PharmD, and Phillip Chung, PharmD, work closely with prescribers to foster judicious antimicrobial use for better patient care and safety, improved clinical outcomes, reduced resistance and fewer healthcare-acquired infections such as CDI.
Requiring providers to justify use of broad-spectrum antibiotics, optimizing dosages and transitioning administration methods (primarily intravenous to oral) and identifying opportunities to routinely de-escalate and streamline treatment regimens are key components of the stewardship plan.
Dr. Ostrowsky and her team focused on 10 healthcare facilities in the Metro New York City/Surrounding Region, four of which were non-intervention facilities and six that implemented specific antimicrobial stewardship interventions. Results of case control studies for antibiotic exposures associated with CDI were used to select specific target antibiotics for which stewardship interventions were developed.
Rates of CDI have been measured before, during and after the implementation of these antimicrobial stewardship activities. The ongoing project also includes continued assessment of infection control/environmental cleaning practices, cost analysis, a program evaluation plan (including prescriber’s perceptions and attitudes about antibiotic prescribing). One goal of the project is the development a Toolkit to aid other facilities in how best to implement stewardship activities and identify the most effective activities to impact prescribing and related outcomes such as CDI at their facility, which would be dissemination throughout the New York metropolitan area and nationally.
For more information, contact the Division of Infectious Diseases at 866-MED-TALK (866-633-8255).
Research Identifies Behavioral Issues in Children with Sleep-Disordered Breathing
This project provides the strongest evidence to date that breathing problems like snoring, mouth breathing and apnea can have serious behavioral and social-emotional consequences for children, according to study leader Karen Bonuck, PhD, at Montefiore’s partner Albert Einstein College of Medicine.
Dr. Bonuck, Professor of Family and Social Medicine, and of Obstetrics & Gynecology and Women’s Health at Einstein, along with her colleagues are studying whether sleep-disordered breathing (SDB) causes behavioral problems in children by affecting the brain in several ways.
SDB can decrease oxygen levels and increase carbon dioxide levels, interrupt the restorative processes of sleep and disrupt the balance of various cellular and chemical relationships. Common causes are enlarged tonsils or adenoids. Their study, the largest and most comprehensive of its kind, was published online in the journal Pediatrics.
The program, which followed 11,000 children for more than six years, was supported by grants from the National Heart, Lung and Blood Institute, part of the National Institutes of Health. Unlike earlier studies, it analyzed the combined effects of snoring, apnea and mouth-breathing patterns. The adverse effects on the brain can result in behavioral difficulties such as impairments in the ability to pay attention, to plan ahead and to organize, hyperactivity and aggressiveness, as well as emotional symptoms and difficulty with peer relationships.
Dr. Bonuck says that children with SDB were 40 to 100 percent more likely to develop neurobehavioral problems by age seven compared with children without breathing problems. She adds that parents and pediatricians alike should be paying closer attention to sleep-disordered breathing in young children, perhaps as early as the first year of life.
For more information, contact Dr. Bonuck at 718-430-4085.
Active Research: Cardiopulmonary Bypass in Pediatric Cardiac Surgery
At the Children's Hospital at Montefiore (CHAM), pediatric heart surgeons are studying the role of the pulsatility, a measure of energy in the circulation. Cardiopulmonary bypass, or the heart-lung machine as it is more commonly known, is used over 350,000 times each year in the U.S. in adults and children who require cardiac surgery.
Physicians from both pediatric and adult cardiac surgery, as well as cardiologists from both pediatric and adult cardiology collaborate to find ways that the heart lung machine can deliver energy that complements the native circulation. Brain, lung and heart function are evaluated, and computer algorithms calculate the optimal mode of bypass.
For more information, contact the Pediatric Heart Center at 718-741-2343.
Discovering New Therapies for Cervical Cancer and Precancerous Lesions
Over the past decade, experts in Montefiore Medical Center’s Advanced Women’s Health Center Clinical Trials and Research Unit have been studying state of the art nonsurgical therapeutic treatments and new prevention strategies targeting Human Papillomavirus (HPV). Cervical cancer and precancerous lesions of the cervix are always start with an HPV infection.
Montefiore has been actively involved in clinical trials targeting and preventing HPV infection in an effort to prevent cervical malignancies. Efforts at Montefiore are focused on patients with pre-malignant conditions of the cervix, offering them different types of therapies targeting the virus. The second phase of trials at Montefiore include both treatment and prevention initiatives. Some of the trials are already in the late stage of clinical trials development.
Precancerous lesions of the cervix affect over 500,000 women in the US per year. Transmitted sexually, HPV is a very common virus that can be easily detected at the time of regular Pap tests. Our ongoing commitment to research is an outstanding benefit to our patients, who can often be enrolled in therapeutic or investigational protocols, some of which are run through the National Cancer Institute (NCI) and the National Institutes of Health (NIH).
Montefiore is also a member of the prestigious NCI supported Gynecology Oncology Group (GOG), a non-profit organization that promotes excellence in gynecologic oncology research and therapy. GOG’s goal is to foster quality research in Gynecologic cancers. They adhere to the strictest standards through all phases of the research process.
For more information, contact the Advanced Women’s Health Center Clinical Trials and Research Unit at 718-405-8390.
Insights and Innovations: Nanomedicine
Nanotechnology are small platforms for delivering cancer therapies directly to the platforms that can be more effective and less damaging or toxic to patients, according to Steven K. Libutti, MD, director of the Montefiore Einstein Center for Cancer Care.
Dr. Libutti, Vice Chair and Professor of Surgery and Genetics at Einstein and Montefiore Medical Center, and Associate Director for Clinical Services at the Albert Einstein Cancer Center, and his colleagues are investigating and testing nanomedicines for use in imaging and treatment against pancreatic tumors. Pancreatic cancer is the fourth-leading cause of all cancer deaths and currently there is no test for early detection of the disease. Nanomedicines are miniscule engineered materials that are 100 billionths of a meter or less in size. The research could lead to novel ways of diagnosing and treating pancreatic as well as ovarian cancer.
A five-year $16 million grant from the National Cancer Institute will take advantage of specialized expertise developed by scientists at Montefiore and Einstein. A total of five individual institutions, comprising the Texas Center for Cancer Nanomedicine, are collaborating on the study. Montefiore is developing nanoparticles that will specifically target unique aspects of the blood vessels found in pancreatic neuroendocrine tumors.
A main focus of Dr. Libutti’s research is the formation of new blood vessels that nourish tumors. He has developed mice that are genetically programmed to form pancreatic neuroendocrine tumors mimicking those seen in people. These mice will be used for testing a variety of nanoparticle-based drugs produced by the other collaborators at the Texas Center for Cancer Nanomedicine. Such studies will reveal whether the particles can effectively target disease locations and deliver therapeutic benefits.
For more information, contact the Montefiore Einstein Center for Cancer Care at 718-862-8840.
Stem Cell Regeneration Following Radiation Exposure
Developing a new stem cell therapy that protects against intestinal injury opens up the possibility of increasing the doses of radiation and improving treatment for abdominal cancers, says Chandan Guha, MD, Vice Chairman and Professor of Radiation Oncology and Pathology at Montefiore and Albert Einstein College of Medicine. Radiation doses for abdominal cancers are kept very low to prevent a serious illness called Radiation-Induced Gastrointestinal Syndrome.
Dr. Guha, recipient of a five-year $10.8 million grant for pioneering stem cell research, and his colleagues, in partnership with the Albert Einstein College of Medicine, are studying methods of developing stem-cell based therapies to treat radiation-induced toxicity and to prevent death in patients. The team investigates R-spondin1, an intestinal stem cell growth factor protein which spurs intestinal stem cell regeneration.
Additionally, they examine what other types of proteins may also have this capability and then clarify the biological mechanisms. This research could lead to drugs that increase the therapeutic effects of cancer treatment while protecting against toxic side effects. Currently, radiation toxicity is treated by transplanting bone marrow, which is not always effective.
The study is funded by a National Institutes of Health grant and is supported by the National Institute of Allergy and Infectious Diseases. It is part of a larger national homeland security initiative focused on developing radiation countermeasures for security purposes. Einstein is one of seven Centers for Medical Countermeasures Against Radiation in the country. The research could have vast clinical implications for cancer patients, military personnel, as well as people exposed to radiation from nuclear energy plant disasters and first responders exposed to terrorist attacks that involve radiation.
For more information, contact the Department of Radiation Oncology at 718-920-2702.