Clinical Research
Orlando Heart & Vascular Institute is committed to pioneering advancements in cardiovascular care through cutting-edge clinical research. Our Clinical Research Division, Certified Physician Investigator Group (CPIG), was established in 2010 with the mission to provide access to state-of-the-art treatments and technologies to our patients.
Through CPIG, we offer participation in carefully selected phase 3 clinical trials that focus on enhancing existing treatments and introducing innovative therapies. These trials aim to improve both the quality of life and long-term outcomes for individuals with cardiovascular disease. By participating in these trials, patients gain access to potentially life-saving medications and devices that may not otherwise be available outside of large academic institutions.
We believe in fully empowering our patients to make informed decisions about their healthcare journey. Participation in clinical trials is entirely voluntary, and declining to participate will never impact the high-quality care provided to our patients. At Orlando Heart & Vascular Institute, we remain dedicated to advancing the forefront of cardiovascular medicine while prioritizing the well-being and autonomy of our patients.
CPIG, is directed under the supervision and guidance of Dr. Ranadive, who oversees the various trials and adherence to the principles of good clinical practices (GCPs), including adequate human subject protection (HSP) which is universally recognized as a critical requirement to the conduct of research involving human subjects. Dr. Ranadive is a member of the Association of Clinical Research Professionals (ACRP), and one of handful of nationally certified physician investigators in the United States. Dr. Ranadive has over 50 publications in various prestigious medical journals.
Clinical Research Coordinator:
Megan Bodiford, our esteemed Clinical Research Coordinator, brings a wealth of expertise and dedication to our team at Certified Physician Investigator Research Group. Graduating with distinction from Seminole State College with an AS in Emergency Medical Services/Paramedics, Megan’s passion for healthcare excellence has been evident throughout her career.
Since joining our organization in August 2014, Megan has diligently served as our Clinical Coordinator, playing a pivotal role in orchestrating and overseeing our clinical research endeavors. With over five years of experience in the medical field, Megan embarked on her research journey in 2014, demonstrating her unwavering commitment to advancing healthcare through innovative research practices.
Known for her exceptional focus and meticulous attention to detail, Megan thrives in the dynamic environment of clinical research and patient care. She firmly believes in the transformative power of research in shaping the future of healthcare and is dedicated to upholding the highest standards of excellence in all our interactions with sponsors.
For inquiries or further information, please don’t hesitate to reach out to Megan Bodiford at [email protected]
Ongoing Clinical Trials
1. Odyssey Outcomes Study: This study is evaluating the ability of investigational drug, called SAR236553, to lower LDL cholesterol and prevent heart attacks or strokes in people who have CHD and been recently hospitalized for a heart attack or unstable angina.
2. Merick Pfizer Trail B1521021: This study is to evaluate cardiovascular outcomes following treatment with Ertugliflozin in subjects with type 2 diabetes mellitus and established vascular disease.
3. Pfizer CV185-267: A phase IV trial to assess the effectivesness of Apixaban compared with usual care anticoagulation in subjects with non-valvular atrial fibrillation undergoing cardioversion.
4. Pfizer CV185-316 Augustus: This study id to evaluate the safety of Apixaban vs. Vitamin K Antagonist and Aspirin vs. Aspirin Placebo in patient with Atrial Fibrillation and Acute Coronary Syndrome or Percutaneous Coronary Intervention
5. Palm Registry: The purpose of this registry is to learn more about doctor prescribed cholesterol lowering medications using the current and previous health guidelines. We also want to learn about barriers to disease prevention and knowledge of treatment goals among patients using cholesterol lowering medications and those that do not. We hope the information gained will help us to understand doctors’ treatment patterns, introduce new treatments and make current treatment guidelines clearer for cholesterol lowering therapies.
Completed Clinical Trials
Bayer BAY59-7939 – X-VERT Trial This study is to determine the effects and safety of using Xarelto to prevent cardiovascular events with patients newly diagnosed with atrial fibrillation scheduled for cardioversion.
Sanofi WAVE I: Real-world Study Evaluating Dronedarone Treatment Patterns and Outcomes in Patients with Atrial Fibrillation
Boehringer Ingelhiem 1160.129 GLORIA-AF This is a registry following various selected therapy choices for patients that have been recently diagnosed with atrial fibriallation. Those patients who are taking Pradaxa will continued to be monitored during a specified time frame.
Boehringer Ingelheim 1160.128 Pradaxa/GIS This study is to follow gastrointestinal symptoms for patients newly perscribed to Pradaxa. If a GIS symptom occurs, patients will be randomized to either take Pradaxa within 30 minutes of food or to take a proton-pump inhibitor.
Takeda Pharmaceuticals, Takada Examine Trial, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to evaluate Cardiovascular Outcomes Following Treatment with Aloglipton in Addition to Standard of Care in Subject with Diabetes and Acute Coronary Syndrome , 2012
Gilead Sciences, A phase 4, Randomized, Double-Blind, Placebo-Controlled, Cross-over Trial to Evaluate the Effects of Ranolazine on Myocardial Perfusion Assessed by Serial Quantitative Exercise SPECT Imaging. 2012
Takayasu PA Stent Report – Pulmonary artery stenting in a patient with Takayasu’s arteritis using a novel balloon-expandable covered stent. Click View
Contact Megan for further information via email. [email protected]
Research Activities
Safety and Effectiveness Evaluation of Eximo Medical’s B-Laser, a hybrid atherectomy device, in subjects affected with infrainguinal PAD
Dr. Weinstock was one of eleven worldwide investigators using the new Eximo Medical B-Laser system in peripheral vascular interventions in the above trial. He was one of the leading enrollers in the study which was recently completed. Based on this study, the Eximo laser received FDA approval and is beginning to be utilized in clinical practice around the country. Dr. Weinstock performed the first case in the world with the commercial version of this new device after FDA approval!
GUIDE-HF Trial
Dr. Weinstock is an investigator in this important heart failure trial. In this study, a small CardioMems sensor (Abbott Medical) is implanted using a catheter advanced to the pulmonary artery of patients with frequent admissions for heart failure. The CardioMems device allows physicians to monitor pulmonary artery and cardiac pressures non-invasively from the patient’s home. The data from this device allows the patient’s physician to make medication adjustments before patients become ill enough to require hospitalization.
ORBIT-II Trial
Dr. Weinstock is one of several investigators at Advent Health Orlando using the CSI DiamondBack Orbital atherectomy catheter to open highly calcified coronary arteries. Such arteries have a high risk of complications with standard balloon angioplasty/stent techniques.
Research Trials at OHVI