Clinical Trials & Research
Research Spotlight Archive
Improving Cardiovascular Disease Outcomes
Atrial fibrillation (AF) is a condition that produces rapid and irregular heartbeats, and increases the risk for stroke and death. Treatments for AF include medical therapy, cardiac catheterization ablation or surgery. While both can cure AF, ablation and surgery scar areas of heart tissue. Scarring—intended to take the bad circuitry out of the equation—is thought to be incidental to its effectiveness. Indeed, many patients in need of heart valve surgery may benefit from an AF procedure to eliminate their condition. To find out if such is the case, 20 centers in the National Institutes of Health (NIH)-sponsored Cardiothoracic Surgical Trials Network enrolled 260 AF patients who also needed mitral-valve surgery. (Up to half of people needing mitral-valve surgery also have AF.)
Results were published in the March 16 issue of the New England Journal of Medicine.
Study coauthor, Robert Michler, MD—Co-Director, Montefiore Einstein Center for Heart and Vascular Care—is a principal investigator on this prestigious NIH award. He and coauthor Joseph J. DeRose, MD, Chief, Division of Cardiothoracic Surgery at Montefiore and surgeons at other participating centers enrolled the patients to randomly undergo surgical ablation or no ablation (control group). Ablation patients were further randomized to one of two types of ablation. All patients were assessed six and 12 months after surgery. Significantly more patients in the ablation group than in the control group were free of AF at both six and 12 months (63.2 percent vs. 29.4%). While the two types of ablation proved equally effective, patients who underwent ablation were significantly more likely than control patients to require implantation of a permanent pacemaker.
Montefiore Einstein Center for Heart and Vascular Care is committed to advancing medical care and science through research and clinical trials. Patients are given opportunities to participate in these early-stage studies and treatment efforts in order to determine if a new therapy or surgical procedure is effective.
$3.5 Million Grant Expands Access to Innovative Care for Hepatitis C
As one of six recipients of the Health Care Innovation Award from the Center for Medicare & Medicaid Services, Montefiore is working to increase access to effective hepatitis C care for patients. Through the grant, Montefiore Einstein researcher Alain Litwin, MD will continue to develop and study models of hepatitis C virus care.
The $3.5 million grant will allow us to identify, diagnose and treat people with hepatitis C (HCV) throughout the Bronx. An estimated 146,500 New Yorkers have chronic hepatitis C, though about half do not know that they are infected. The award, called Project INSPIRE NYC, will increase the number of patients starting hepatitis C therapy, strengthen management of behavioral health problems, and reduce hospitalizations and emergency department visits.
Over three years, we will use an integrated model of care for Medicare and Medicaid patients who are at risk for hepatitis C. Primary care champions will work closely with care coordinators and specialists to increase access to effective hepatitis C care for patients. HCV care coordinators will provide care coordination, navigation, health promotion, and medication adherence to offer each enrollee a patient-centered medical home. Also available to patients will be a peer educator, a person who was cured of hepatitis C, who can share his or her experiences and help patients navigate through the process.
The project will be supported by a telemedicine system linking a hepatologist, infectious diseases specialist, and mental health provider with the primary care provider. Its goal is to further educate the physician and increase the capacity of patients served.
“This innovative model of care builds on our strengths and commitment to our community and will avert deadly consequences of chronic hepatitis C for many people living in the Bronx,” says Dr. Litwin. “We will be able to make a significant impact in combating hepatitis C by innovating the way we deliver health care, on par with other innovations. That’s the whole point of Project INSPIRE NYC.”
Alain Litwin, MD, is Professor of Medicine at Montefiore Medical Center and Albert Einstein College of Medicine.
While cancer mortality rates are declining, minority and underserved populations have yet to show improvement. Through an NIH grant, Montefiore-Einstein researchers Joseph Sparano, MD, Mark Einstein, MD, MS and Bruce Rapkin, PhD are working to change this.
As one of 12 sites to participate in the NCI Community Oncology Research Program (NCORP), Montefiore will use the $3.4 million grant to reduce healthcare disparities in cancer care. The program will be conducted at Montefiore Einstein Center for Cancer Care, our premier cancer center that provides patient-centered care for prevention, diagnosis and treatment of cancer. The NCORP research will be directed by three investigators: Dr. Sparano will lead efforts in cancer therapeutics; Dr. Einstein will oversee cancer prevention; and Dr. Rapkin will focus on cancer control and delivery.
“Albert Einstein Cancer Center has played a key leadership role in therapeutic cancer trials and has received funding from NCI for nearly four decades to support its role as a main member institution of the Eastern Cooperative Oncology Group,” says Dr. Sparano. “The NCORP funding will support expanding activities in the areas of cancer prevention, cancer control and cancer care delivery research.”
In addition to leading cancer clinical research at Montefiore, Dr. Sparano has focused on enhancing the access of minority populations to cancer clinical trials as an essential component of contemporary cancer care. “Cancer mortality rates are declining rapidly as a result of improved treatment, screening and prevention, but improvements have lagged in minority populations,” adds Dr. Sparano. “Clinical trials have provided a foundation for much of this improvement. The NCORP mechanism will allow us to integrate new approaches that may address this disparity.”
Joseph Sparano, MD, is Professor of Medicine and of Obstetrics and Gynecology and Women's Health, and Associate Director of Clinical Research, Einstein; and Vice Chairman of Medical Oncology, Center for Cancer Care.
Mark Einstein, MD, MS, is Professor and Director of Oncology Research in the Department of Obstetrics and Gynecology and Women's Health, Einstein; and Vice Chair of Research for Obstetrics and Gynecology and Women's Health, Center for Cancer Care.
Bruce Rapkin, PhD, is Professor of Epidemiology and Population Health at Einstein and Center for Cancer Care.
Waging a Battle Against Cervical Cancer
Mark Einstein, MD, director of clinical research for women's health and gynecologic oncology at Montefiore, is at the center of great progress currently being made against cervical cancer. Dr. Einstein's research—pinpointing the specific cells that cause cervical cancer when infected by HPV—could probably be quickly translated into new tests to screen for and treat cervical cancer. Learn more.
People who are frail are more vulnerable to serious complications from falls or surgery and more susceptible to infection. Understanding why some seniors do not experience a loss of balance or strength and do not suffer from abnormal gait may help doctors prevent and treat such physical decline.
The National Institute on Aging, part of the National Institutes of Health, has awarded a five-year $3.3 million grant to fund a genetics research project—led by Montefiore Einstein researchers Nir J. Barzilai, MD, and Joe Verghese, MD—to identify genes that protect against frailty in old age.
The research taps into the resources of Einstein's LonGenity Research Study, which builds upon the Longevity Genes Project, an ongoing 15-year study with more than 500 Ashkenazi Jews over the age of 95. LonGenity compares the genetics of the centenarians and their children with those with usual survival. Over the past 10 years, Dr. Barzilai's team has identified several biological markers that may explain their extreme longevity.
The researchers will build on a pilot study funded by the American Federation for Aging Research that linked exceptional longevity to improved physical function and reduced risk of frailty. The team plans to further those initial efforts to identify gene variants that keep frailty at bay, explore biological pathways that may lead to frailty, and develop drugs that mimic the effect of those frailty-preventing genes.
Montefiore attending physician Nir Barzilai, MD, is director of the Institute for Aging Research and the Ingeborg and Ira Leon Rennert Chair in Aging Research at Einstein.
Joe Verghese, MBBS , Director of the Montefiore Einstein Center for the Aging Brain is the Murray D. Gross Memorial Faculty Scholar in Gerontology at Einstein and chief of geriatrics at Einstein and Montefiore.
Montefiore researchers received a $3.7 million grant from the National Institute on Drug Abuse at the National Institutes of Health (NIH) that will allow Montefiore researchers to develop an anti-smoking program for HIV-infected smokers.
The five-year grant supports the study of Positively Smoke Free (PSF)—an intensive group cessation program designed specifically for HIV-infected smokers that uses cognitive behavioral therapy and includes eight 90-minute sessions for groups of six to eight people led by a psychologist and HIV-infected peer.
In the original pilot study of 145 patients, 19.2 percent quit smoking vs. 9.7 percent in the control group. Since quit rates almost doubled with the PSF program, NIH recognized the promise of the program and awarded a larger grant.
"Approximately 60 percent of individuals living with HIV in the United States are smokers, which is triple the national average, and the majority are interested in quitting," explains Jonathan Shuter, MD, Director of Clinical Research, Montefiore AIDS Center and Professor of Clinical Medicine, Albert Einstein College of Medicine . "However, there are unique psychosocial characteristics among many HIV-infected smokers who are not effectively reached through traditional smoking cessation programs."
The randomized trial will investigate the efficacy of PSF compared with the current standard of care, which consists of brief advice about quitting smoking during a patient's regular office visit. The study also will assess specific behaviors that may be linked to successful cessation among HIV-infected smokers.
The goal is to enroll 450 patients during the next three and a half years. Abstinence from cigarettes will be followed for six months after the end of the sessions. Their refrain from smoking will be confirmed with exhaled carbon monoxide. In addition to two sites at Montefiore, 100 patients will be enrolled at Georgetown University.
Exercise Cuts Risks for Female Heart Patients
Heart disease is the leading cause of death for women in the United States, responsible for one in four female deaths. Although women are twice as likely as men to develop heart failure following heart attack or cardiac ischemia, they are less often directed to complete an exercise program.
New Montefiore Einstein research suggests that this should not be the case. Exercise can help patients with heart failure, but it seems women reap the benefits more than men. In the largest examination of the effects of exercise in patients with heart failure, women reduced their risk for death or repeat hospitalization by 26 percent, compared with 10 percent in men.
The findings suggest physicians should consider exercise as a component of treatment for female patients with heart failure, as they do for male patients, according to researcher Ileana Piña, MD, M.P.H., Associate Chief, Academic Affairs, Division of Cardiology, Montefiore Medical Center, Professor, Medicine and Epidemiology & Population Health, Albert Einstein College of Medicine. “Heart disease has a major impact on women. Our goal is for these findings to greatly impact the management of this challenging syndrome.”
This study—sponsored by the National Heart, Lung, and Blood Institute and published in the Journal of the American College of Cardiology: Heart Failure—is the first to formally link exercise training to health in women with cardiovascular disease.
Study Investigates Causes of Miscarriage
One in five pregnancies ends in miscarriage, with most of these happening in the first three months. Recurrent miscarriage, defined as two or more miscarriages, happens in up to 5 percent of couples attempting to conceive.
To find the “whys” behind the data, Montefiore and Albert Einstein College of Medicine researchers investigated the causes. The result: A new test that may provide a useful technique to gain a better understanding as to why miscarriage occurs in some women.
The technique used in this study—rescue karyotyping—allows physicians to get important genetic information from tissue that had not been tested at the time of the miscarriage. As part of standard hospital procedure, tissue from miscarriages is set in paraffin for archival use, and the karyotyping test is performed on DNA extracted from this tissue.
In this retrospective study of 20 samples from 17 women, genetic testing was successfully performed on 16 samples that had been archived for as long as four years. Of those samples, eight showed chromosomal variants and abnormalities. This is an important alternative when conventional karyotyping is not available or cannot be used for a specific sample.
“Montefiore and Einstein have worked together to develop an innovative model based on research, which allows us to develop novel diagnostic and treatment options and, in parallel, to quickly bring new advances to the clinic,” said Dr. Zev Williams, MD, PhD, Director, Program for Early and Recurrent Pregnancy Loss, Montefiore and Einstein, Assistant Professor, Obstetrics & Gynecology and Women's Health, and Genetics, Einstein, and corresponding author of the study. “This represents a new and emerging model in medicine—where the lab and clinic are brought closer in order to speed the pace of discovery and treatment.” Learn about the Program for Early and Recurrent Pregnancy Loss.
HIV/AIDS in Women
Montefiore Medical Center and Albert Einstein College of Medicine received a $16 million grant from the National Institutes of Health (NIH) to investigate the impact of HIV and AIDS on women.
Kathryn M. Anastos, MD, has served as one of the principal investigators of the Women's Interagency HIV Study since it was established in 1993. Dr. Anastos has partnered with researchers to determine the clinical care HIV-positive women should receive for human papillomavirus (HPV), implement an electronic records system to collect and analyze data on patients receiving antiretroviral therapy in central Africa, and develop clinical services and build research capacity in Rwanda.