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

ALECARDIO: A Study With Aleglitazar in Patients With a Recent Acute Coronary Syndrome and Type 2 Diabetes Mellitus

This double-blind, parallel, two-arm study will evaluate the potential to reduce cardiovascular risk, the tolerability and long-term safety profile of aleglitazar compared to placebo on top of standard care in patients with recent acute coronary syndrome (ACS) and type 2 diabetes mellitus. Patients will be randomized to receive either aleglitazar or placebo once daily as oral doses. The study will last until at least 950 events occur, but time on study treatment will be for at least 2.5 years. The target sample size is 6000-7000 patients.
Lead Coordinator: Jadie Dayton

(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

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

DAL-OUTCOMES 2: "A Phase 3b, Multi-Center, Double-Blind, Placebo-Controlled, Parallel Group, Study to Evaluate the Effect of Dalcetrapib 600 mg on Cardiovascular (CV) Events in Adult Patients with Stable Coronary Heart Disease (CHD), CHD Risk Equivalents or at Elevated Risk for Cardiovascular Disease (CVD)"

The study targets a high risk population, and will focus on a patient population of slightly lower Cardio Vascular (CV) risk.  Dalcetrapib 600mg will be evaluated on how it effects adult patients with stable Coronary Heart Disease (CHD), CHD risk equivalents, or at elevated risk for Carddio Vascular Disease (CVD).  It is indicated to reduce cardiovascular mortality and morbidity in these patients.  Dalcetrapib is a cholesteryl ester transfer protein (CETP), a CETP modulator shown to induce dose-related decreases in CETP activity and increases in HDL-C levels.  Evidence accumulated so far in ongoing trials on the effect and mechanism of this action of raising HDL-C through CETP modulation assumes there may be a beneficial effect on CV mortality and morbidity in the population to be recruited for dal-Outcomes 2.  Long term safety and tolerability of dalcetrapib will be assessed as well as its effect on lipid markers and biomarkers of CV risk.
Lead Coordinator: Gloria Stagi Coyle

EZ-NG - EZ Holdco Inc.

EZ-Holdco Inc. has developed two devices for the measurement of gastric content pH.  The devices, EZ-NG and EZ-pH, rapidly check gastric pH by aspirating gastric contents into the device through a nasogastric (NG) tube and causing a color change in the device.  The color change is then compared to the reference indicator on the device to determine a pH value of the aspirate.  Currently there is no bedside rapid way to check gastric pH that protects the clinician from being exposed to the aspirate.  The primary objective of this study is to validate the accuracy of the pH measurement of gastric fluid on the devices by comparing the reading on the 2 devices to a standard clinically approved pH probe.  Subjects will either have an NG tube placed as part of their clinical care or will be having an NG tube placed as part of a planned surgical procedure.   
Lead Coordinator: Jadie Dayton

EXAMINE: Cardiovascular Outcomes Study of Alogliptin in Subjects With Type 2 Diabetes and Acute Coronary Syndrome

The purpose of this study is to evaluate the cardiovascular outcomes of alogliptin, once daily (QD), compared with placebo, in addition to standard of care, in subjects with type 2 diabetes mellitus and acute coronary syndrome. 
Lead Coordinator: Jadie Dayton

ION US Post-Approval Study

The purpose of this study is to compile real-world clinical outcomes data for the ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System in routine clinical practice.  The ION™ stent is the third-generation Boston Scientific (BSC) paclitaxel-eluting coronary stent. It is designed for improved performance specific to deliverability and radio-opacity while maintaining a similar drug release profile of the TAXUS Express and TAXUS Liberté stents.  Post-approval studies of drug-eluting stents (DES) provide an opportunity to observe and assess patient outcomes and technology performance in a real-world setting.
Lead Coordinator: Abby Ensign Snow

ISOL 8: Trellis Registry

The ISOL-8 Study involves retrospective, data collection designed to describe the clinical effects of early thrombus removal on the post-thrombotic syndrome (PTS) using an isolated pharmacomechanical thrombolysis device, the Trellis™ peripheral infusion system in acute deep venous thrombosis patients.  The data being collected by this study were prospectively collected by physicians over a 24 month follow-up period. The purpose of the study is to aggregate this data to describe the aforementioned clinical effects.  The study is not intended to modify, extend or further describe the labeling of the Trellis peripheral infusion system as cleared by the FDA. 
Lead Coordinator: Juliet Bala

PreSERV 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

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

SELECT-PCI (ROCHE): A Study of RO4905417 in Patients With Non ST-Elevation Myocardial Infarction (Non-STEMI) Undergoing Percutaneous Coronary Intervention

This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of RO4905417 (a p-selectin inhibitor) in patients with non ST-elevation myocardial infarction (Non-STEMI) undergoing percutaneous coronary intervention (PCI). Patients will be randomized to receive an intravenous infusion of either 5 mg/kg RO4905417 or 20 mg/kg RO4905417 or placebo before PCI. Follow-up will be for 4 months.
Lead Coordinator: Betsy Szymanski

TAO: Effect of Otamixaban Versus Unfractionated Heparin + Eptifibatide in Patients With Unstable Angina/Non ST Elevation Myocardial Infarction Undergoing Early Invasive Strategy

Randomized, double-blind, triple dummy, parallel group study to demonstrate the superior efficacy of Otamixaban ( a direct factor X inhibitor) as compared with heparin + eptifibatide in acute coronary syndrome scheduled to undergo PCI.  Up to the interim analysis, patients are randomized to one of two Otamixaban arms or the control arm (UFH + Eptifibatide). Then after interim analysis, patients will be randomized to the continued Otamixaban arm or the control arm (UFH + Eptifibatide). The total duration of the study period per subject will be 180 days..
Lead Coordinator: Betsy Szymanski

TAXUS Libertē Post Approval Study

The TAXUS Libertē Post-Approval Study is an FDA-mandated prospective, multi-center study designed to collect real-world safety and clinical outcomes in approximately 4,200 patients receiving one or more TAXUS Liberté Paclitaxel-Eluting Stents and prasugrel as part of a dual antiplatelet therapy (DAPT) drug regimen.
Lead Coordinator: Beth Posey

TRANSLATE (Eli Lilly):  Treatment With Adenosine Diphosphate (ADP) Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events After Acute Coronary Syndrome (TRANSLATE-ACS)

The TReatment with ADP receptor iNhibitorS: Longitudinal Assessment of Treatment Patterns and Events after Acute Coronary Syndrome (TRANSLATE-ACS) study is a prospective, observational longitudinal study to evaluate the real world effectiveness and use of prasugrel and other ADP receptor inhibitor therapies among myocardial infarction (MI) patients treated with percutaneous coronary intervention (PCI) during the index hospitalization. Patient management and treatment decisions are at the discretion of the care team per routine clinical practice. Approximately 17,000 patients will be enrolled at approximately 350 sites in the United States. Follow-up will be conducted through 15 months in approximately 15,650 patients.
Lead Coordinator: Cynthia Paysor

VISTA-16 Trial: Evaluation of Safety and Efficacy of Short-term A-002 Treatment in Subjects With Acute Coronary Syndrome

The objective of this study is to evaluate the safety and efficacy of short-term A-002 (an anti-inflammatory agent) treatment on morbidity and mortality when added to atorvastatin and standard of care in subjects with an acute coronary syndrome (ACS). Up to 6500 subjects will be recruited from up to 500 centers worldwide. In addition to study drug (A-002 or placebo) atorvastatin ≥20 mg/day must be given to all subjects for 16 weeks. The entire follow-up period will be 6 months.
Lead Coordinator: Cynthia Paysor