• Gill Clinical Research Unit

    The Gill Heart & Vascular Institute Cardiology Clinical Research Center is designed to facilitate all aspects of patient-based clinical research. This includes coordination of Phase I-IV multicenter drug and device trials, investigator-initiated protocols as well as 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 Heart 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.


  • Clinical trials

    CURRENT ENROLLING CLINICAL TRIALS

    AlloMap Registry (CareDx, Inc.)
    Amulet (St. Jude Medical)
    BMS CV002004 (Bristol-Myers Squibb Research and Development)
    CardioMEMS HF System PAS (Post Approval Study) (St. Jude Medical)
    COMPASSION S3 (Edwards Lifesciences)
    DREAM HF (MESOBLAST)
    FAME 3 (Stanford University)
    ISCHEMIA (NHLBI/NYUSOM)
    MOMENTUM 3 CAP (St. Jude Medical)
    smartADHERE (Janssen Scientific Affairs, LLC)
    Spyral HTN ON Meds (Medtronic)
    Spyral HTN OFF Meds (Medtronic)

    AlloMap Registry (CareDx, Inc.)

    PI: Navin Rajagopalan, MD

    • To analyze medical records and observe clinical outcomes in heart transplant recipients who receive regular AlloMap testing as part of allograft rejection surveillance.

    For more information about this study, contact:

    Rebekah Evans, RN
    859-323-8663
    Email: rastan2@uky.edu

    Return to list »


    Amulet (St. Jude Medical)

    Comparison of Amplatzer™ Amulet™ LAA occluder safety and efficacy in patients with non-valvular atrial fibrillation to Boston Scientific LAA occluder.

    PI: John Gurley, MD

    • Patients over the age of 18 with documented paroxysmal, persistent, or permanent non-valvular atrial fibrillation who are also deemed suitable for LAA closure.

    For more information about this study, contact:

    Yvonne Taul, RN
    859-218-1644
    Email: Yvonne.taul@uky.edu

    Return to list »


    BMS CV002004 (Bristol-Myers Squibb Research and Development)

    A Longitudinal Evaluation of Disease & Fibrosis Biomarkers in Different Groups of Heart Failure Patients to Enhance the Early Clinical Development of Compounds with Anti-fibrotic Activity in the Heart

    PI: Vincent Sorrell, MD

    • To compare the blood levels and imaging studies in stable and acute heart failure patients

    For more information about this study, contact:

    Heather Shinall
    859-323-5259
    Email: h.shinall@uky.edu

    Return to list »


    CardioMEMS HF System PAS (Post Approval Study) (St. Jude Medical)

    PI: Maya Guglin, MD, PhD

    • Continued collection of safety and efficacy data following FDA approval of device

    For more information about this study, contact:

    Rebekah Evans, RN
    859-323-8663
    Email: rastan2@uky.edu

    Return to list »


    COMPASSION S3 (Edwards Lifesciences)

    Congenital Multicenter trial of Pulmonic vAlve dysfunction Studying the SAPIEN 3 interventIONal THV

    PI: Andrew Leventhal, MD, PhD

    • To determine safety and efficacy of the Edwards Sapien 3 Transcatheter Heart Valve System in patients with dysfunctional right ventricular outflow tract with clinical indication for intervention

    For more information about this study, contact:

    Jennifer Isaacs
    859-323-4738
    Email: Jennifer.isaacs@uky.edu

    Return to list »


    DREAM HF (MESOBLAST)

    Efficacy and Safety Study of Allogeneic stem cells in Patients with Chronic Heart Failure Due to Left Ventricular Systolic Dysfunction of Either Ischemic or Nonischemic Etiology

    PI: Ahmed Abdel-Latif, MD, PhD

    • Restoring the function of damaged heart muscle with experimental study product cells

    For more information about this study, contact:

    Heather Shinall
    859-323-5259
    Email: h.shinall@uky.edu

    Return to list »


    FAME 3 (Stanford University)

    Fractional flow reserve versus angiography for multivessel evaluation (FAME) 3 Trail

    PI: Ahmed Abdel-Latif, MD, PhD (VA)

    • A comparison of fractional flow reserve-guided percutaneous coronary intervention and coronary artery bypass graft surgery in patients with multivessel coronary artery disease

    For more information about this study, contact:

    Yvonne Taul, RN
    859-218-1644
    Email: Yvonne.taul@uky.edu

    Return to list »


    ISCHEMIA (NHLBI/NYUSOM)

    International Study of Comparative Health Effectiveness with Medical and Invasive Approaches invasive strategy ( initial management with cath) vs. conservative strategy (initial management with optimal medical therapy [OMT] and provisional cath if OMT fails) in ischemic patients

    PI: David Booth, MD (UK and VA)

    • Patients with at least moderate ischemia on a stress imaging test

    For more information about this study, contact:

    Yvonne Taul, RN
    859-218-1644
    Email: Yvonne.taul@uky.edu

    Return to list »


    MOMENTUM 3 CAP (St. Jude Medical)

    Multi-Center Study of MagLev Technology in Patients Undergoing MCS Therapy with HeartMate 3™

    PI: Maya Guglin, MD, PhD

    For more information about this study, contact:

    Jennifer Isaacs
    859-323-4738
    Email: Jennifer.isaacs@uky.edu

    Return to list »


    smartADHERE (Janssen Scientific Affairs, LLC)

    smartADHERE - Smartphones to Improve Rivaroxaban ADHEREnce in Atrial Fibrillation

    PI: Yousef Darrat, MD

    • To evaluate the effectiveness of an intervention with a smart phone application compared to standard of care in atrial fibrillation patients treated with rivaroxaban.

    For more information about this study, contact:

    Yvonne Taul, RN
    859-218-1644
    Email: Yvonne.taul@uky.edu

    Return to list »


    Spyral HTN ON Meds (Medtronic)

    Global Clinical Study of Renal Denervation with the Symplicity Spyral multi-electrode renal denervation system in patients with Uncontrolled Hypertension on Standard Medical Therapy

    PI: Khaled Ziada, MD

    For more information about this study, contact:

    Heather Shinall
    859-323-5259
    Email: h.shinall@uky.edu 

    Return to list »


    Spyral HTN OFF Meds (Medtronic)

    Global Clinical Study of Renal Denervation with the Symplicity Spyral multi-electrode renal denervation system in patients with Uncontrolled Hypertension in the absence of antihypertensive medications

    PI: Khaled Ziada, MD

    For more information about this study, contact:

    Heather Shinall
    859-323-5259
    Email: h.shinall@uky.edu 

    Return to list »

  • Clinical research team

    Khaled Ziada, MD
    Director, Gill Heart & Vascular Institute Cardiology Research Center

    Jennifer Isaacs, MS, MS, CCRP
    Cardiovascular Clinical Research Manager
    859-323-4738
    jennifer.isaacs@uky.edu

    Mary Roycraft
    Regulatory Coordinator
    859-323-8658
    mary.roycraft@uky.edu

    Research Coordinators

    Rebekah Evans, RN
    859-323-8663
    rebekah.evans@uky.edu

    Caroline Rodgers, RN, CCRC
    859-323-1082
    caroline.rodgers@uky.edu

    Heather Shinall, MA, CCRP
    859-323-5259
    h.shinall@uky.edu

    Yvonne Taul, RN, CCRC
    859-218-1644
    yvonne.taul@uky.edu

    Alexandra Telfair-Hull 
    859-218-2880 
    alexandra.hull@uky.edu

    Viktoria Bulkley, RN, BSN
    859-323-8516
    v.bulkley@uky.edu

    The division supports a clinical trial section, led by Khaled Ziada, MD, and clinical research manager Jennifer Isaacs, MS, MS, CCRP. Phase 1 - IV 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 Clinical and Translational Science (CTSA) Program 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.

  • Please Note:

    Study coordinators and research nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician, we can help you find a UK doctor or clinic location to meet your health care needs. 

    Although the studies described on this website may have potential benefits as described, the University of Kentucky and its physicians and affiliated hospitals cannot and do not guarantee or promise that you will receive any benefits from participating in a study. 

    The information posted on this site is consistent with the research reviewed and approved by the University of Kentucky Institutional Review Board (IRB). However, the IRB has not reviewed all material posted on this site. Contact the IRB if you have questions regarding your rights as a research participant. Also contact the IRB if you have questions, complaint, or concerns which you do not feel you can discuss with the investigator. The UK IRB may be reached by phone at 859-257-9428 or toll free at 1-866-400-9428.