Active Research Studies

The Dr. Kiran C. Patel Research Institute oversees dozens of research studies every year across many clinical disciplines. Patients that are admitted to our hospitals who meet specific criteria for studies may be asked to participate in a research study, but are never obligated to. Following is a list of research studies that are currently active at our hospitals.

ABLATE: AF Registry Trial (AtriCure Synergy Bipolar RF Energy Lesions for Non-paroxysmal Forms of Atrial Fibrillation Treatment During Concomitant On-Pump Endo/Epicardial Cardiac Surgery)

ABLATE AF is a prospective, non-randomized multi-center clinical trial to demonstrate the safety and effectiveness of the AtriCure Bipolar System for treating non-paroxysmal forms of atrial fibrillation.
Lead Coordinator: Cynthia Paysor

ABSORBE RCT: Evaluation of Absorb™ Bioresorbable Vascular Scaffold (Absorb™ BVS) System Abbott Stent Study A Clinical Evaluation of Absorb BVS, the Everolimus Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects with de novo Native Coronary Artery Lesions (Abbott)

To evaluate the applicability and transferability of the didactic Absorb BVS physician training plan to US clinical practice. A non-randomized, single-arm, open label group assignment of subjects treated with Absorb BVS. The Lead-In Phase will enroll/register subjects prior to the randomization phase of ABSORB RCT.  ABSORB III will evaluate the safety and effectiveness of the Absorb BVS system compared to the XIENCE in the treatment of subjects with ischemic heart disease caused by up to two de novo native coronary lesions in separate vessels.
Lead Coordinator: Beth Posey

(ALERTS) AngelMed for Early Recognition and Treatment of STEMI

A prospective, randomized multicenter study of subjects with a high-risk of having a myocardial infarction (MI) due to acute coronary syndrome or bypass surgery.  Subjects will have the AngelMed Guardian device implanted to measure their heart’s rhythm intracardially.  The device will alert the patient when it detects electrogram characteristics set by the physician.  Subjects will be randomized to 2 groups for the first 6 months of the study: alerts turned on or alerts turned off.  After the first 6 months, all subjects will have alerts turned on for the remainder of the study, which is 3-5 years.  The primary efficacy objective is to determine that the Guardian System reduces the composite of Cardiac or unexplained death, new Q-wave MI and time to door at a medical facility >2 hours.  The primary safety objective is to demonstrate that the proportion of implanted subjects who are free from system-related complications at six months post programming is at least 90%.
Lead Coordinator: Abby Ensign Snow

ATTRACT: Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis

The purpose of this study is to determine if the use of adjunctive Pharmacomechanical Catheter Directed Thrombolysis, which includes the intrathrombus administration of rt-PA--Activase (Alteplase), can prevent the post-thrombotic syndrome (PTS) in patients with symptomatic proximal deep vein thrombosis (DVT) as compared with optimal standard DVT therapy alone. 
Lead Coordinator: Juliet Bala

AWARE AKI M13-796 A Safety and Efficacy Trial of Multiple Dosing Regimens of ABT-719 for thePrevention of Acute Kidney Injury in Subjects Undergoing High Risk Cardiac Surgery: Acute Kidney Prevention

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Trial of Multiple Dosing Regimens of ABT-719 for the Prevention of Acute Kidney Injury in Subjects Undergoing High Risk Cardiac Surgery
Lead Coordinator: Yvonne Gopsill

CANTOS: (Novartis) Cardiovascular Risk Reduction Study (Reduction in Recurrent Major CV Disease Events)

A Phase 3, a randomized, double-blind, placebo-controlled, event-driven trial of quarterly subcutaneous canukinumab (a fully human monoclonal antibody for treatment of inflammatory disease) in the prevention of recurrent cardiovascular events among stable post-myocardial infarction patients with elevated hsCRP. A secondary hypothesis, that canakinumab treatment in patients with MI and pre-diabetes, will prevent new onset diabetes will also be tested. The study will continue until 694 cardiovascular endpoints are accrued in approximately 7,302 randomized patients.
Lead Coordinator: Jadie Dayton

CARTO 3: Efficacy, Safety and Efficiency Study of CARTO® 3 System Guided THERMOCOOL® Catheter Ablation Versus Fluoroscopy Guided Ablation with the Pulmonary Vein Ablation Catheter® (PVAC®) (CLARITY-AF)

System and Real Time Intracardiac Ultrasound for Ablation of Drug Refractory Recurrent Symptomatic Paroxysmal AF: Acute Procedural Outcomes Study. A prospective, non- randomized observational study for subjects undergoing RF ablation of drug refractory recurrent symptomatic paroxysmal AF who meet I/E criteria. Subjects will undergo an ablation procedure performed using the NAVISTAR THERMOCOOL SF catheter with the CARTO 3 system and a SOUNDSTAR Ultrasound catheter.
Lead Coordinator: Michele Fewster

COLOR An Observational Study of Cholesterol in Coronary Arteries

The registry of patients receiving InfraReDx LipiScan for detection of lipid core containing plaques of interest.  (LCP) These plaques are rich in cholesterol. The way that cholesterol and other lipids deposit with the coronary artery is unique to each patient. This study is an organized attempt to observe the LCP and the variety of ways that it presents in patients as detected by this recently approved device. This information will be used for physician training and to observe the behavior of the LCP in response to no therapy and currently approved therapies. The purpose of this project is further medical knowledge of the LCP and its treatment.
Lead Coordinator: Abby Ensign Snow

(eTRIS) (Quintiles) A Randomized, Open-Label, Parallel-Group, Multi-Center Study for the Evaluation of Efficacy and Safety of Edoxaban Monotherapy Versus Low Molecular Weight (LMW) Heparin/Warfarin in Subjects With Symptomatic Deep-Vein Thrombosis

Assess the relative change in thrombus volume as determined by two assessments (Baseline and Day 14-21) with magnetic resonance imaging (MRI) in subjects with deep-vein thrombosis (DVT) treated with either an edoxaban monotherapy regimen or a low molecular weight (LMW) heparin/warfarin regimen.
Lead Coordinator: Gloria Stagi Coyle

EUCLID: Examining Use of tiCagreLor In paD

 A randomized, double-blind, parallel group, multicentre phase IIIb study to compare ticagrelor with Clopidogrel treatment on the risk of cardiovascular death, myocardial infarction and ischemic stroke in patients with established Peripheral Artery Disease (PAD)
A randomized, double-blind, parallel group, multicentre phase IIIb study to compare ticagrelor with Clopidogrel treatment on the risk of cardiovascular death, myocardial infarction and ischemic stroke in patients with established Peripheral Artery Disease. 
(EUCLID Examining Use of tiCagreLor In paD)
Lead Coordinator: Juliet Bala

EVITA: Evaluation of Varenicline (Champix) in Smoking Cessation for Patients Post-Acute Coronary Syndrome

In patients who have suffered a heart attack Varenicline has been recently shown to increase the number of otherwise healthy people who quit smoking compared to placebo (sugar pill). Although varenicline has been shown to reduce smoking in healthy populations, its effectiveness in patients recovering from a heart attack is unknown. The EVITA trial will help answer this question.
Lead Coordinator: Michele Fewster

GLORIA-AF: Global Registry on Long-Term Oral Anti-thrombotic TReatment In PAtients with Atrial Fibrillation (Phase I)

This study constitutes Phase I of the Registry Program. The main objective of this study is to characterize the newly diagnosed non-valvular AF patient population at risk for stroke and the selection of antithrombotic treatment for stroke prevention in a real-world setting before dabigatran etexilate is approved for the prevention of strokes and systemic emboli in patients with non-valvular AF in different regions of the world.
Lead Coordinator: Gloria Stagi Coyle

INGEVITY(TM): Active Fixation and Passive Fixation Pace/ Sense Lead Clinical Study 

The objective of this study is to gather data to establish the safety, performance and effectiveness of the INGEVITY pace/ sense leads.  A prospective, non- randomized, multi-center, global clinical study to establish the safety, performance, and effectiveness of the INGEVITY active and passive fixation pace/ sense leads.
Lead Coordinator: Beth Posey

ODYSSEY: Evaluation of Cardiovascular Outcomes after an Acute Coronary Syndrome during Treatment with SAR236553 (REGN727) (ODYSSEY Outcomes)

To compare the effect of SAR236553 (REGN727) with placebo on the occurrence of cardiovascular events (composite endpoint of coronary heart disease (CHD) death, non-fatal myocardial infarction (MI), fatal and non-fatal ischemic stroke, unstable angina requiring hospitalization) in patients who have experienced an acute coronary syndrome (ACS) event 4 to 16 weeks prior to randomization and are treated with evidence-based medical and dietary management of dyslipidemia.
Lead Coordinator: Cynthia Paysor

PARACHUTE IV  (Percutaneous Ventricular Restoration in Chronic Heart Failure due to Ischemic Heart DiseasE)  A Pivotal Trial to Establish Efficacy and Long Term Safety of the Parachute Implant System

A Prospective, Multicenter, Randomized, Controlled, Pivotal Trial of the CardioKinetix Parachute Implant. CardioKinetix has developed a catheter-based treatment for patients with left ventricular dilation after an anterior MI. The implantable device, called the Parachute Implant, is a partitioning membrane deployed within the compromised ventricle. The Parachute Implant Isolates the dysfunctional region of the ventricle and decreases functional chamber volume
Treatment of ischemic heart failure.
Lead Coordinator: Cynthia Paysor

PHYSICIAN WELLNESS STUDY

The purpose is to evaluate the feasibility of a convenient health screening program for physicians. Evaluate if physician perceptions of health status change over time. The benefits will be having the knowledge about your health that may prompt follow-up care if indicated. Wellness education and coaching. Outcomes used to design future health screening programs for physicians.
Lead Coordinator: Peter Bath, D. Min, MBA

PreSERVE AMI AMORCYTE: "A Prospective Randomized Double Blinded Placebo Controlled Phase II Trial of Intracoronary Infusion of AMR-001, a Bone Marrow Derived Autologous CD34+ Selected Cell Product, in Patients with Acute Myocardial Infarction"

A prospective, randomized, double blinded, placebo controlled phase II trial of intra-coronary infusion of AMR-001, a bone marrow derived autologous CD34 selected cell product, in patients with acute myocardial infarction. The primary objective of the study is to determine safety and the effect of the product on myocardial perfusion using the resting total severity score measured by gated SPECT MPI. Assessment will occur at baseline and six months post infusion, in subjects with ST elevation myocardial infarction and an ejection fraction of ≤ 48%.
Lead Coordinator: Betsy Szymanski

(RENEW) BAXTER CD 34 - Efficacy and Safety of Targeted Intramyocardial Delivery of Auto CD34+ Stem Cells for Improving Exercise Capacity in Subjects With Refractory Angina (RENEW)

The purpose of the study is to assess the safety and efficacy of targeted intramyocardial delivery of Auto-CD34+ cells for increasing exercise time and amelioration of angina symptoms in subjects with refractory angina and chronic myocardial ischemia.
Lead Coordinator: Gloria Stagi Coyle

River PCI: A Phase 3, Ranolazine for Incomplete Vessel Revascularization Post-Percutaneous Coronary Intervention 

The primary objective to the trial is to evaluate the efficacy of ranolazine as compared with placebo when used as part of standard medical therapy in chronic angina subjects with incomplete revascularization postpercutaneous coronary intervention (PCI) on the incidence of major adverse cardiovascular events (MACE), defined as the composite of cardiovascular (CV) death, myocardial infarction (MI), or hospitalization for ischemia or angina.
Lead Coordinator: Cynthia Paysor

SAPPHIRE: Worldwide: Stenting and Angioplasty With Protection in Patients At High-Risk for Endarterectomy

The primary objective of this study is to assess the outcomes of stenting with distal protection in the treatment of obstructive carotid artery disease in the high-risk population. The devices to be utilized are the Cordis PRECISE® Nitinol Stent Systems (5.5F and 6F) and the Cordis ANGIOGUARD™ XP Emboli Capture Guidewire (ECGW).
Lead Coordinator: Gloria Stagi Coyle