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  • Gill Clinical Research Unit

    The Gill Heart Institute Cardiology Research Center is designed to facilitate all aspects of patient-based clinical research. This includes coordination of Phase I-IV multicenter trials, support of the infrastructure for clinical trials as well as education of faculty and fellows in clinical research methodology.

    Since its inception, the Gill Heart Institute Cardiology Research Center has been a top enroller in multicenter trials including novel devices for patent foramen ovale (PFO) closure, left atrial pressure monitoring to treat heart failure and percutaneous closure of atrial septal defect (ASD).  


  • Clinical trials

    CURRENT ENROLLING CLINICAL TRIALS

    CADENCE (Otsuka)
    GLAGOV (Amgen)
    ISCHEMIA (NHLBI/NYUSOM)
    REDUCE (GORE)
    CIRT (NHLBI/Brigham and Women’s)
    VEST/VEST Registry (U of CA-SF)
    (VA) DIVA
    Enhance CRT (SJM)
    ABSORB IV (Abbott)
    TCAP (Vanderbilt and Astra Zeneca)
    Upcoming trials

    CADENCE (Otsuka)

    Ascending Dose Study of OPC-108459 Intravenous Infusions in Patients with Paroxysmal and Persistent Atrial Fibrillation

    PI: Samy-Claude Elayi, MD    

    • Ages 18-85
    • Paroxysmal and persistent atrial fibrillation
    • Must determine eligibility prior to cardioversion

    For more information about this study, contact:

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

    Return to list » 


    GLAGOV (Amgen)

    Randomized, placebo-controlled, parallel group study to determine the effects of AMG 145 treatment on atherosclerotic disease burden as measured by intravascular ultrasound in subjects undergoing coronary catheterization.

    PI: Khaled Ziada, MD

    • Clinically indicated coronary angiogram with evidence of CAD

    For more information about this study, contact:

    Caroline Rodgers, RN  
    859-323-1082
    Email: caroline.rodgers@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

    • 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 » 


    REDUCE (GORE)

    GORE® HELEX® Septal Occluder / GORE® Septal Occluder for Patent Foramen Ovale (PFO) Closure in Stroke Patients - The Gore REDUCE Clinical Study (HLX 06-03)

    PI: John Gurley, MD

    • Ages 18-60
    • Presence of cryptogenic ischemic stroke or TIA of presumed embolic infarction verified by a neurologist within 180 days prior to randomization
    • Presence of Patent Foramen Ovale (PFO), as determined initially by positive bubble study utilizing transesophageal echocardiography (TEE), demonstrating spontaneous right-to-left shunting or right-to-left shunting during Valsalva maneuver.
    • Absence of an identifiable source of thromboembolism in the systemic circulation

    For more information about this study, contact:

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

    Return to list » 


    CIRT (NHLBI/Brigham and Women’s)

    Cardiovascular Inflammation Reduction Trial

    PI: Alison Bailey, MD

    • Investigating whether taking low-dose methotrexate reduces heart attacks, strokes, or death in people with type 2 diabetes or metabolic syndrome that have had a heart attack
    • Documented myocardial infarction within the past five years, completed any planned coronary revascularization procedures associated with the qualifying event, and have been clinically stable for at least 60 days prior to screening; the qualifying prior myocardial infarction must be documented either by hospital records or by evidence on current ECG of Q waves in two contiguous leads and/or an imaging test demonstrating wall motion abnormality or scar

    For more information about this study, contact:

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

    Return to list » 


    VEST/VEST Registry (U of CA-SF)

    Non-invasive wearable automatic defibrillator vest will reduce mortality in first 90 days post MI in pts w/ LV dysfunction (≤35%)

    PI: Samy-Claude Elayi, MD 

    • STEMI / NSTEMI with EF ≤ 35%
    • LifeVest vs. medical management for 3 months
    • Registry is continuation of data collection for up to 8 years annually

    For more information about this study, contact:

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

    Return to list » 


    (VA) DIVA 

    Drug-Eluting Stents vs. Bare Metal Stents in Saphenous Vein Graft Angioplasty

    PI: Khaled Ziada, MD

    • Patients with hx of CABG who are scheduled for PCI to SVG

    For more information about this study, contact:

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

    Return to list » 


    Enhance CRT (SJM)

    CRT Implant Strategy using the longest electrical delay for non-LBB patients; randomized, post-market pilot study

    PI: Gustavo Morales, MD

    • Patients with non-left bundle branch block, eligible for bi-ventricular ICD implant

    For more information about this study, contact:

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

    Return to list » 


    ABSORB IV (Abbott)

    A Clinical Evaluation of Absorb™ BVS, the Everolimus Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects with de Novo Native Coronary Artery Lesions.

    PI: Khaled Ziada, MD

    • Patients with indication for elective LHC and possible PCI

    For more information about this study, contact:

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

    Return to list » 


    TCAP (Vanderbilt and Astra Zeneca)

    Randomized Trial of Ticagrelor for Severe Community Acquired Pneumonia

    PI: Susan Smyth, MD, PhD

    • Patients with Severe Community Acquired Pneumonia, within 48 hours of admission

    For more information about this study, contact:

          Travis Sexton, PhD    
    859-323-3617

    Return to list » 


    Upcoming:

    ALLSTAR (Capricor) - Allogeneic Heart Stem Cells to Achieve Myocardial Regeneration in patients with ischemic heart failure

    PI: Ahmed Abdel-Latif, MD, PhD


    Dream HF (TEVA) - 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


    Camillia TIMI 61 (Eisai) - Effect of Long-Term Treatment with BELVIQ (lorcaserin HC1) on the Incidence of Major Adverse Cardiovascular Events and Conversion to Type 2 Diabetes Mellitus in Obese and Overweight Subjects with Cardiovascular Disease or Multiple Cardiovascular Risk Factors

    PI: Alison Bailey, MD


    Aegis-1 (CLS) - Phase 2b, Multi-center, Randomized, Placebo-controlled, Dose-ranging Study to Investigate the Safety and Tolerability of Multiple Dose Administration of CSL112 in Subjects with Acute Myocardial Infarction

    PI: Alison Bailey, MD

    Return to list » 


  • 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. 

Page last updated: 10/1/2014 11:05:32 AM