Mercy Research is one of the nation’s largest fully integrated, community health system-based research organization. We conduct research in all our available service lines, and we manage more than 600 clinical trials with data from locations throughout our system. We offer:
“A physician is not only in a position to improve health of a singular person but also in a position to advance medical therapies through research and education to improve the health of a population. Mercy Research has seamlessly allowed us to start physician-initiated trials in Missouri, and, importantly, participate in large international trials to advance the care of patients not only in the United States but the world.” – Christopher Stout, MD, Mercy Vascular and Endovascular Surgery Clinic
Dr. Farid Sadaka was named Mercy Research’s inaugural Researcher of the Year for 2018. He is honored for his dedication to research and for exemplifying:
“To become proficient and an expert at critical care medicine, the involvement in research is very important for it makes me a better clinician, there is no question about it,” said Dr. Sadaka. “By doing research I stay up-to-date on evidence-based medicine, which ultimately improves Mercy and makes it the best for our patients,” he added. His areas of research interest include sepsis and neuroscience, particularly traumatic brain injury and temperature management.
Dr. Sadaka earned a medical degree from American University of Beirut. After training in internal medicine, Dr. Sadaka went on to an internal medicine residency at St. Louis University Hospital, followed by a critical care fellowship at St. Louis University Hospital and Mercy Hospital St. Louis.
He began as a faculty physician with the Critical Care Medicine Training Program. He is also currently the trauma and neuro ICU medical director at Mercy Hospital St. Louis. He is an adjunct professor of internal medicine and neurology and is the program director in critical care medicine at St. Louis University School of Medicine.
“The Intellectual Challenge of Research Makes Me a Better Physician” – Dr. Vito Mantese talks about the Zenith® p-Branch™ Pivotal Study
Dr. Vito Mantese has dedicated his 30-year career as a vascular surgeon to Mercy. Dr. Mantese earned his medical degree from St. Louis University School of Medicine, where he also completed a two- year residency in general surgery. He then completed a research fellowship at Duke University Medical Center, followed by two more years of general surgery residency at St. Louis University Medical Center, a year of vascular surgery research and clinical fellowship at Sydney University in Australia and a year of vascular surgery fellowship at Baylor University Medical Center.
Dr. Mantese has been actively involved in aortic, peripheral vascular and other vascular clinical research trials for 20 years as both a principal investigator and a sub-investigator. Vascular surgery is an active field, with technology advancing rapidly. Dr. Mantese finds participating in clinical trials makes him “a better clinician personally, as well as enabling our clinical program to grow and improve.” By participating in clinical trials, he provides earlier patient access to technology and enhanced care for his patients.
Endovascular care is replacing surgical intervention for the treatment of abdominal aortic aneurysms (AAA), because of the fenestrated aortic stent. However, this treatment requires the fabrication of a custom stent, based on patient-specific measurements, which can take six weeks or more.
Dr. Mantese is currently involved with the Zenith® p-Branch™ Pivotal Study, evaluating the safety and effectiveness of an off-the-shelf fenestrated stent for AAA repair that could eventually allow for urgent/emergent treatment of AAA via endovascular care instead of surgical intervention.
Dr. Mantese explains that “taking the time with patients is critical to interact and help them understand what the clinical trial is all about.” He said that “you need to give the patients time to understand the benefits and the risks associated with the study.” He finds that the availability of new technology at Mercy and the accessibility of physicians and investigators is attracting patients to this study.
Dr. Mantese says that the commitment to be a principal investigator requires “personal time and sacrifice to stay current with study responsibilities,” yet it “provides an intellectual challenge and drives me to become a better physician.”
FDA Approves World’s First Neuromodulation Device for Heart Failure Based on the BeAT-HF Trial:
Mercy Research is actively participating in the Baroreflex Activation Therapy for Heart Failure (BeAT-HF) study. Recently the FDA has granted premarket approval for the BAROSTIM NEO device for advanced heart failure patients who are not indicated for cardiac resynchronization therapy based on the BeAT-HF trial.
FDA Approves First Drug Designed to Prevent Migraines:
Aimovig, the first medicine to prevent migraines approved by the FDA, was based on two clinical trials that occurred at Mercy. Mercy patients had access to Aimovig five years before it was available to the public.
FDA approves transcatheter aortic valve replacement (TAVR) for low risk patients based on the Medtronic TAVR in Low Risk Patients trial.:
Mercy Research is a participating institution in the Medtronic TAVR in Low Risk Patients trial. On August 16, 2019, the FDA approved an expanded indication for TAVR to include patients at low risk for open heart surgery based on data from the Medtronic TAVR in Low Risk Patients trial. Drs. Robert Merritt, Mercy Clinic Cardiology - Whiteside and Sirish Parvathaneni, Mercy Clinic Cardiac, Thoracic and Vascular Surgery - Whiteside are co-principal investigators for this research study, which is located in Springfield, MO. Mercy Research enrolled 55 subjects into the trial, and 29 subjects underwent the TAVR procedure.
This expanded indication has brought benefit to not just the Mercy study participants in the Medtronic TAVR in Low Risk Patients trial, but to all Mercy patients by providing a less invasive aortic valve replacement treatment option that was previously only available to subjects deemed to be at intermediate, high, or extreme risk for open heart surgery. This less invasive treatment may allow patients to leave the hospital sooner and get back to their active life. There are risks associated with the TAVR procedure. Please discuss these risks with your doctor.
Mercy Research Participates in Nationwide Project that Uses One-of-a-Kind Breast Ultrasound System:
Mercy Research is participating in a 10,000 patient, multi-center research project evaluating a novel breast ultrasound device, called SoftVue™, for women who have dense breast tissue.
SoftVue™ is the world’s first three-dimensional, whole-breast ultrasound system that uses a one-of-a-kind circular transducer. It was created to assist physicians in distinguishing normal tissue from areas in the breast that may require further testing. Mercy is one of only 8 centers nationwide participating in the groundbreaking project.
Qualified participants will have both screening mammography and SoftVue™ exams. Imaging information gathered from the project will compare SoftVue™to digital mammography and measure SoftVue™’s effectiveness in finding cancers that are not seen with mammography alone. The study data will support an application submission to the U.S. Food and Drug Administration to investigate if SoftVue™ can be approved as a supplemental screening indication for women with dense breasts.
For the majority of women, mammography is effective at helping ensure the early detection of breast cancer. For women with dense breast tissue, mammography by itself may not be enough. Dense breast tissue, which occurs in more than 40 percent of women nationwide, can mask potential tumors during mammography screening, so women are often sent for secondary diagnostic testing, such as breast ultrasound. Studies have shown breast cancers were found in dense breasts by ultrasound that could not be seen by doctors with mammography.
“SoftVue™ has the potential to provide women with dense breast tissue greater peace of mind when it comes to their annual exams,” said Dr. Satheavy Moore, Lead Breast Radiologist of Mercy Washington. “Traditionally, women with dense breast tissue have been sent for additional imaging using handheld ultrasound technology, which can be time consuming and may be difficult to perform consistently for each scan. In contrast, the SoftVue™ exam is fast, simple and easy for use with women who have dense breast tissue.”
SoftVue™ is a fully automated, gentle and comfortable system that conducts scans while a woman relaxes on her stomach with her breast supported in a warm water bath. A 360-degree ring transducer images the entire breast, including chest wall, in a single pass as it moves down the breast, without the radiation and compression associated with other imaging systems. The unique circular transducer can evaluate multiple distinctive tissue qualities to provide physicians with an understanding of the tissue within the whole breast from the chest wall to the nipple. The captured signals are analyzed using sophisticated algorithms that provide cross-sectional slices of the entire volume of breast tissue.
The SoftVue™ systems being tested are experimental prototype versions of 510(k) cleared devices. The diagnostic breast ultrasound imaging is not intended for use as a replacement for screening mammography. Currently, the technology is only in use at research sites.
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