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

  • OPTIMIZER SMART
  • REVERSE-IT
  • REVEALPLAQUE
  • MK-5475-007
  • RIN-PH-304

Electrophysiology

OPTIMIZER SMART POST-APPROVAL STUDY

PI: Aaron Hesselson, MD
Coordinator: Ben Rushing, CCRC 859-323-5259

Objective: To evaluate data such as cardiac outcomes, quality of life, mortality and functionality. Long-term data are also needed to assess complication rates and potential interactions with other implantable devices in the intended patient population. The post-approval study (PAS) protocol has been designed to address these concerns in a real-world setting.

AMPLATZER™, PFO OCCLUDER, AND AMPLATZER TALISMAN™, PFO OCCLUDER PAS ("PFO PAS") POST-APPROVAL STUDY

PI: John Gurley, MD                         
Coordinator:  Stephanie Morris, CCRP 859-323-5366

Objective:  To demonstrate safety of the AmplatzerTM PFO Occluder and AmplatzerTM TalismanTM PFO Occluder by assessing the 30-day rate of device- or procedure-related serious adverse events including those that led to death.

General Cardiology

REVERSE-IT – A phase 3, multicenter, open-label, single-arm study of PB2452 in ticagrelor-treated patients with uncontrolled major or life-threatening bleeding or who require urgent surgery or an invasive procedure 

PI: John Kotter, MD
Coordinator: Jennifer Isaacs, CCRP 859-323-4738

Objective: To demonstrate reversal of the antiplatelet effects of ticagrelor with IV infusion of PB2452 and to demonstrate the clinical efficacy of PB2452 by assessment of hemostasis in ticagrelor-treated patients with uncontrolled major or life-threatening bleeding in an open-label, single-cohort study.

The REVEALPLAQUE study – A pRospEctiVe, multicEnter study to AnaLyze PLAQUE using CCTA

PI: Steve Leung, MD
Coordinator: Travis Sexton, PhD 859-323-1082

Objective: To evaluate the level of agreement between noninvasive CCTA-based quantification and characterization of coronary atherosclerosis and invasive IVUS.

Pulmonary Hypertension

MK-5475-007 – A phase 2/3, multicenter, randomized, double-blind, placebo-controlled, adaptive design study to evaluate the efficacy and safety of MK-5475 in adults with pulmonary arterial hypertension

PI: David Booth, MD
Coordinator: Travis Sexton, PhD 859-323-1082

Objective: Two cohorts to evaluate the effect of MK-5475 

  • versus placebo on the pulmonary vascular resistance (PVR) at week 12.
  • versus placebo on six-minute walk distance (6MWD) at week 12.

RIN-PH-304 – A phase 3, randomized, placebo-controlled, double-blind, adaptive study to evaluate the safety and efficacy of inhaled treprostinil in patients with pulmonary hypertension due to chronic obstructive pulmonary disease (PH-COPD)

PI: Jimmy Smith, MD
Coordinator: Travis Sexton, PhD 859-323-1082

Objectives: The primary objective of this study is to demonstrate the efficacy of inhaled treprostinil compared to placebo in improving exercise ability as measured by change from baseline in 6MWD following 12 weeks of active treatment in subjects with PH-COPD.

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
859-323-4738 
jennifer.isaacs@uky.edu

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

Research Coordinators

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

Travis Sexton, PhD
859-323-1082
trsext2@uky.edu