Clinical Trials & Research
Montefiore is the University Hospital for Albert Einstein College of Medicine. This unique partnership brings together expertise across disciplines and yields an extensive portfolio of biomedical research, with an emphasis on translating basic science in the lab to pioneering treatments and therapies. Montefiore physicians are discovering novel solutions that advance the future of healthcare and treatments:
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.
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.
Clinical Trials Database
Patients at Montefiore have access to an extensive array of clinical research studies and clinical trials designed to determine the safety and efficacy of new treatments, while helping eligible patients gain access to innovative treatments. Montefiore physicians BS researchers are involved in more than 400 clinical trials and research studies to evaluate the effectiveness and safety of innovative treatments and diagnostics.
Use our comprehensive search tool to find a clinical trial that that meets your needs.