MWH Research Department Ongoing Clinical Research Studies The following studies are the current MWH Research Department studies. For more information on each study, please follow the link provided for that study, or you may call 540.741.4655. Heart Studies GLORIA-AF Registry Program - Second and Third Phases https://www.clinicaltrials.gov/ct2/show/NCT01468701?term=Long+Term+Oral+Anti-ThRombotic+Treatments&rank=2 This is a 3-year Global Registry study that evaluates the Long Term Oral Anti-ThRombotic Treatments In patients with a history of Atrial Fibrillation (AF). The main purpose of this observational research study is to investigate the differences between patients that may influence the choice of anticoagulation medication that is selected for the prevention of stroke in AF patients and collect information on health-related events and treatments related to AF in a “real-world” setting and potential side effects of anticoagulant treatment. Boehringer-Ingelheim Sponsored Studies: http//:www.Boehringer-Ingelheim.com Emperial trial 1245-0167 & 1245-0168 https://www.clinicaltrials.gov/ct2/show/NCT03448419?term=Emperial+trial&rank=1 https://www.clinicaltrials.gov/ct2/show/NCT03448406?term=Emperial+trial&rank=2 Emperial Trials 1245-0167: Purpose of this study: To investigate the safety and effects of empagliflozin (Jardiance) on exercise ability and heart failure symptoms in subjects with HFpEF (Heart Failure with preserved Ejection Fracture, of LVEF>40%) compared to a placebo. In this study you will either get the study drug or a placebo. Empagliflozin has not been approved by the US Food and Drug Administration (FDA) as a treatment for HFpEF. This study drug is experimental for this study. It has been approved by the FDA to treat type 2 Diabetes. Emperial Trials 1245-0168: Purpose of this study: To investigate the safety and effects of empagliflozin (Jardiance) on exercise ability and heart failure symptoms in subjects with HFrEF, (Heart Failure with reduced Ejection Fracture, LVEF<40%) compared to a placebo. In this study you will either get the study drug or a placebo. Empagliflozin has not been approved by the US Food and Drug Administration (FDA) as a treatment for HFrEF. This study drug is experimental for this study. It has been approved by the FDA to treat type 2 Diabetes. XIENCE 90:A Safety Evaluation of 3-month DAPT After XIENCE Implantation for HIGH BLEEDING RISK (HBR) Patients. https://www.clinicaltrials.gov/ct2/show/NCT03218787?term=xience+90&rank=1 This Study is being done to evaluate the safety of taking the CE mark and FDA-approved P2Y12 inhibitor drugs (e.g. clopidogrel (Plavix®), prasugrel (Effient®), or ticagrelor (Brilinta®) for 3 months AND aspirin with no specified time limit after the implantation of any commercially approved XIENCE stents for patients at high risk of bleeding. The XIENCE stent is not being investigated in this Study, nor are the antiplatelet drugs. The purpose of the Study is to gather information on the use of the P2Y12 inhibitor drug for 3 months for patients receiving XIENCE stents. Abbott Sponsored Studies www.abbott.com ABSORB III Randomized Controlled Trial (RCT) (ABSORB III) https://www.clinicaltrials.gov/ct2/show/NCT01751906?term=ABSORB+BVS&rank=6 The purpose of this Study is to assess the safety and effectiveness of treating blockages in the coronary (heart) arteries (blood vessels) with an investigational (experimental) device called Absorb™ Bioresorbable Vascular Scaffold (BVS) System (the “Absorb BVS”), compared to a commercially approved metallic stent coated with medication (drug-eluting stent) XIENCE family stent. OPTISURE Lead Post Approval Study https://www.clinicaltrials.gov/ct2/show/record/NCT02235545?term=optisure&rank=1 This is a 5-year OptisureTM Lead study. Patients have been implanted with one of St. Jude Medical’s family of high voltage right ventricular leads within the past 30-days or are having one of St. Jude Medical’s family of high voltage right ventricular leads implanted. These products are already approved by the FDA and we are studying their long-term performance. Cancer Studies Breast Registry Study of Breast Microseed Treatment http://www.breastmicroseed.com/ https://www.clinicaltrials.gov/ct2/show/NCT02701244?term=concure&rank=1 A multicenter registry study of Breast Microseed treatment for early stage breast cancer. Further research is still needed to evaluate its safety in a multicenter setting and to detect serious adverse events when a larger number of patients are treated by a larger group of practitioners. Lung Cancer Study http://www.oncocyte.com/ This is a prospective, multicenter study developing a non-invasive, confirmatory liquid biopsy test (blood test) as an intermediate step to confirm the absence of cancer between imaging modalities (LDCTs) by detecting suspicious lung nodules and downstream invasive procedures that determine if the nodules are malignant. This liquid biopsy test is intended to facilitate clinical decision making in lung cancer diagnosis. You may be eligible for this research study for early detection of lung cancer. Principal Investigator: Timothy Sherwood, MD Purpose of study: To evaluate an experimental blood test for the detection of lung cancer Who can participate: Current or past smokers over 21 years old Lung nodules less than or equal to 3 cm Nodules must be newly diagnosed or stable for at least one year or more CT scan within last 90 days How you can help: Participate, if eligible - Call 540.741.4655 Patient requirement: One time blood draw with no additional follow up Patient compensation: $25.00 gift card Physician Initiated Studies The impact of postmortem CT on the injury severity score (ISS) for deceased trauma patients. This is a retrospective physician-initiated study that utilized the trauma registry database of all trauma patients who arrived at MWH deceased or death occurred within the first 24 hours of their hospital stay and received a postmortem CT. The study evaluates what extent of the Injury Severity Score (ISS) is altered in a deceased trauma patient after a postmortem CT, which thereby provides a more accurate retrospective assessment of their likelihood of survival. The study’s hypothesis is a postmortem CT will result in a significant increase the patients' ISS. A Retrospective Look at the Outcomes of Infants Given DART Protocol on Non- Invasive Respiratory Support. This is a retrospective physician-initiated study to compare the outcomes between two groups of Very Low Birth Weight (VLBW) infants, one group who received the DART protocol (Dexamethasone: A Randomized Trial) while on non-invasive respiratory support versus the other group who did not receive the DART protocol on non-invasive respiratory support. The purpose of this study is to determine if the DART protocol is successful in weaning VLBW infants off non-invasive respiratory support with no increase in short-term adverse outcomes.