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Clinical Trials at Gill

The UK Gill Heart & Vascular Institute Cardiology Clinical Research Center is designed to facilitate all aspects of patient-based clinical research. This includes coordination of Phase 1-4 multicenter drug and device trials, investigator-initiated protocols and translational studies. Multidisciplinary collaborations within the Gill and across UK HealthCare are key to our successful patient enrollment. Avid support of the infrastructure for clinical trials as well as education of faculty, fellows and Gill staff in clinical research methodology is at the core of our continued success.

Since its inception, the Gill Heart & Vascular Institute Cardiology Clinical Research Center has been at the forefront in leading multicenter trials investigating novel devices for patent foramen ovale (PFO) closure and left atrial pressure monitoring to treat heart failure as well as novel drug therapy for acute coronary syndrome (ACS), post-stent (post PCI) treatment, and atrial fibrillation.

The Gill offers innovative, leading-edge cardiac care including stem cell regenerative medicine for advanced heart failure, novel lipid lowering therapy and the latest catheter-based interventions.

  • Currently enrolling clinical trials

    • BIO LIBRA (Biotronik) Electrophysiology
    • BIOFLOW (Biotronik) Interventional Cardiology
    • PRECISE (HeartFlow, Inc.) General Cardiology
    • WARRIOR (Department of Defense) Women's Cardiology

    BIO LIBRA - AnaLysIs of Both Sex and Device Specific FactoRs on Outcomes in PAtients with Non-Ischemic Cardiomyopathy

    PI: Aaron Hesselson, MD

    Coordinator: Ben Rushing 859-323-5259

    Objective: To evaluate the combined risk of all-cause mortality and treated ventricular tachycardia (VT) or ventricular fibrillation (VF) events by subject sex and by implanted device type. All-cause mortality, VT or VF alone, risk of cardiac death, and sudden cardiac death will be analyzed for the total cohort, as well as by subject sex and by the implanted device type.

    BIOFLOW-VII – A Prospective Multicenter Study to Confirm the SaFety and Effectiveness of the Orsiro SiroLimus Eluting Coronary Stent System in the Treatment Of Subjects With up to Three De Novo or Restenotic Coronary Artery Lesions – VII

    PI: Naoki Misumida, MD

    Coordinator: Ben Rushing 859-323-5259

    Objective: To evaluate this post-approval study is to confirm that the clinical performance of the Orsiro stent in a real-world setting is similar to the clinical performance observed for Orsiro in the BIOFLOW-V Investigational Device Exemption pivotal trial, as a condition of the US Food and Drug Administration (FDA) approval (P170030).

    The PRECISE Protocol: Prospective Randomized Trial of the Optimal Evaluation of Cardiac Symptoms and Revascularization (PRECISE)

    PI: Vincent L. Sorrell, MD

    Coordinator: Chris Webb, 859-323-1082

    Objective: To assess clinical outcomes, decision making regarding noninvasive testing and invasive angiography, and costs using a precision evaluation strategy as compared to a usual care strategy in participants with stable symptoms suggestive of significant coronary artery disease. The precision evaluation strategy will be based on a pre-test risk assessment and will incorporate cCTA with selective FFRCT and guideline-recommended care with symptom and risk factor management and no immediately planned testing.

    Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD (WARRIOR)

    PI: Gretchen Wells, MD, PhD

    Coordinator: Denise Sparks, RN, 859-218-6713

    Objective: To determine whether intensive medication treatment to modify risk factors and vascular function in women patients with coronary arteries showing no flow limit obstruction but with cardiac symptoms (i.e., chest pain, shortness of breath) will reduce the patient's likelihood of dying, having a heart attack, stroke/TIA or being hospitalized for cardiac reasons. The results will provide evidence data necessary to inform future guidelines regarding how best to treat this growing population of patients, and ultimately improve the patient's cardiac health and quality of life and reduce health-care costs.

  • Clinical research team

    John Kotter, MD
    Director, Gill Heart & Vascular Institute Cardiology Research Center

    Jennifer Isaacs, MS, MS, CCRP
    Clinical Research Administrative Director
    Cardiovascular and Radiology Services
    Gill Heart & Vascular Institute Clinical Research Organization
    Phone: 859-323-4738
    Fax: 859-257-7383
    Email: jennifer.isaacs@uky.edu

    Stephanie Morris, CCRP
    Clinical Research Operations Manager – Cardiovascular and Radiology Services
    Gill Heart & Vascular Institute Clinical Research Organization
    Phone: 859-323-5366
    Fax: 859-257-7383
    Email: stephanie.a.morris@uky.edu

    Research Coordinators

    Chris Webb, MS, MS, RN
    Phone: 859-323-1082
    Email: christopher.webb1@uky.edu

    Ben Rushing, CCRC
    Phone: 859-323-5259
    Email: ben.rushing@uky.edu

    The division supports a clinical trial section, led by John Kotter, MD, and Clinical Research Director Jennifer Isaacs, MS, MS, CCRP. Phase 1-4 drug and device clinical trials across a multitude of areas including structural heart disease, coronary artery disease, heart failure and electrophysiology are currently in progress.

    The strength of our clinical research efforts, particularly regarding innovative catheter-based approaches to heart and vascular disease, is unmatched. We conduct leading-edge cardiovascular treatment approaches including renal denervation, left atrial pressure monitoring for heart failure, resorbable coronary stents and stem cell regenerative medicine. Historically, we have been a top enroller in multicenter trials investigating novel devices for PFO closure, left atrial pressure monitoring (to treat heart failure) and ASD closure as well as novel drugs for treatment of ACS and the prevention of secondary coronary events.

    Our strength and commitment to clinical trial research increases the accessibility of state-of-the-art treatments to patients across Kentucky that would otherwise not exist in this region of the country. The University of Kentucky’s Center for Clinical and Translational Science (CCTS) awarded by the National Institutes of Health places the university in an elite group of 60 biomedical research institutions poised to solve the toughest challenges in medicine and surgery using innovative approaches.