Campuses: Home button

Research & Clinical Trials

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.

If you are interested in participating in one of our trials, you will need to complete a Release of Information form.

Following is a list of research studies that are currently active at our hospitals.

ARTEMIS: Affordability & Real-World Antiplatelet Treatment Effectiveness after Myocardial Infarction Study
Current patterns of P2Y12 receptor inhibitor use provide an excellent opportunity to test the impact of copayment reduction on clinician choice of medication, patient adherence, and clinical outcomes. The ARTEMIS trial is a practical multicenter, cluster- randomized clinical trial that will assess the impact of copayment reduction by equalizing the copayment of clopidogrel and ticagrelor.
Lead Coordinator: Kyle Mullen

BioFLOW V BioTRONIC Reprise III Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions
The objective of this study is to assess the safety and efficacy of the Orsiro Sirolimus Eluting Coronary Stent System in the treatment of subjects with up to three native de novo or restenotic (standard PTCA only) coronary artery lesions compared to the Xience coronary stent system.
Lead Coordinator:Yvonne Gopsill

BIONICS: BioNIR Drug Eluting Stent System in Coronary Stenosis
The BioNIR study aims to show that the BioNIR ridaforolimus eluting stent is non-inferior to the Resolute zotarolimus-eluting stent for the primary clinical endpoint of target lesion failure (TLF) at 12 months; that it is non-inferior to the Resolute for the secondary endpoint of angiographic in-stent late loss at 13 months; and that it is more cost-effective.
Lead Coordinator: Diane Bashton

CAPTIVATE: Evaluation of Automatic Threshold Algorithms
This study will evaluate the PaceSafe Right Ventricular Autothreshold (RVAT) and Left Ventricular Autothreshold (LVAT) features for AUTOGEN Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices.
Lead Coordinator: Beth Posey

CARIN: A Prospective, Comparative, Randomized, Multi-Center, Blinded, Placebo-Controlled, Phase 2a Study of the Safety and Efficacy of CMX-2043 for Peri-Procedural Injury Protection in Subjects Undergoing Coronary Angiography at Risk of Radio-contrast Induced Nephropathy
The objective of this study is to evaluate CMX-2043 for prevention of renal and cardiac injury associated with coronary angiography in patients with acute coronary syndrome (ACS), but excluding ST-elevation myocardial infarction (STEMI) patients.
Lead Coordinator: Beth Posey

Department of Defense: Application of Near Infrared Spectroscopy, Intravascular Ultrasound and the Coronary Calcium Score to Predict Adverse Coronary
This is a five year study to compare methods of technology that include coronary ultrasound (IVUS), tomography for detection of coronary calcium(EBCT), infrared spectroscopy to detect lipid plaques (NIRS) and angiography in patients undergoing cardiac catheterization as predictors for future cardiac events.
Lead Coordinator: Yvonne Gopsill

EKOS ACCESS PTS (Chronic DVT): ACCelerated Thrombolysis for Post-Thrombotic Syndrome Using the EKOS System (ACCESS PTS)
To evaluate the efficacy of ultrasound accelerated thrombolysis using the EkoSonic® Endovascular System with standard infusion of thrombolytic drug for post-thrombotic syndrome and chronic venous occlusion. The EkoSonic® Endovascular System employs high frequency (2- 3MHz), low power ultrasound to facilitate the delivery of therapeutic agents to the intravascular treatment site in the peripheral vasculature.
Lead Corrdinator: Juliet Bala

JUVENTAS JTCS-005 (Registry) to Assess the Ongoing Safety for Subjects that have been Randomized and Completed a Juventas Sponsored Heart Failure Protocol under IND # 14203A Phase II Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety and Efficacy of a Single Dose of JVS-100 Administered by Endomyocardial Injection to Cohorts of Adults with Ischemic Heart Failure
This is an exploratory registry that will include subjects who have been randomized to receive JVS-100 treatment (at one of multiple doses) or placebo by one of a number of delivery systems (e.g. endomyocardial injection, retrograde infusion) in a previous Juventas clinical trial. This will assess the ongoing safety of subjects including morbidity/mortality parameters as they relate to heart failure; and to track any newly diagnosed malignancies or hospitalizations. These results will be used to better understand the long term safety profile of JVS-100 and design of future late-stage clinical trials.
Lead Coordinator: Brian Nordgren

LATITUDE TIMI 60: LosmApimod To Inhibit p38 MAP kinase as a therapeutic target and modify outcomes after an acute coronary syndrome
This study will test whether losmapimod can safely reduce the risk of a subsequent cardiovascular event (such as death, heart attack, or near heart attack requiring urgent treatment (when started immediately after ACS (specifically, heart attack). Patients who present with heart attack and qualify for the study will be randomly assigned to receive 3 months treatment with either losmapimod twice daily or placebo, which will be administered in addition to the usual standard of care therapies for heart attack. Following the in-hospital period, subjects will return for outpatient visits at 4 and 12 weeks, as well as a follow up visit at 24 weeks.
Lead Coordinator: Cynthia Paysor

LIBERTY: Observational Study to Evaluate PAD Treatment Clinical and Economic Outcomes
The purpose of this study is to evaluate acute and long term clinical and economic outcomes of endovascular procedures to treat Peripheral Arterial Disease (PAD). Prospective, Observational, Multi-Center Clinical Study to Evaluate Acute and Long Term Clinical and Economic Outcomes of Endovascular Device Intervention in Patients With Distal Outflow Peripheral Arterial Disease (PAD).
Lead Coordinator: Diane Bashton

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

OPTIMIZER®: Evaluate Safety and Efficacy of the OPTIMIZER® System in Subjects With Ejection Fraction Between 25% and 45% Moderate-to-Severe Heart Failure: FIX-HF-5C
The Impulse Dynamics FIX-HF-5C Study is a prospective, multicenter, randomized study to evaluate the safety and efficacy of cardiac contractility modulation (CCM) signals delivered by the implantable OPTIMIZER™ System in patients with NYHA class III and IV heart failure and an ejection fraction 25-45%.
Lead Coordinator: Brian Nordgren

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

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

To compile acute procedural performance and clinical outcomes data for the Promus PREMIER everolimus-eluting coronary stent system in understudied/underserved patient populations, including women and minorities.
Lead Corrdinator: Juliet Bala

RE-DUAL PCI: Evaluation of Dual Therapy With Dabigatran vs. Triple Therapy With Warfarin in Patients With AF That Undergo a PCI With Stenting
A prospective randomized, open label, blinded endpoint study to evaluate dual antithrombotic therapy with dabigatran etexilate (110 mg or 150 mg BID) plus clopidogrel or ticagrelor vs. triple therapy strategy with warfarin plus clopidogrel or ticagrelor and aspirin in patients with non- valvular atrial fibrillation that have undergone a percutaneous coronary intervention (PCI) with stenting.This event-driven RE-DUAL PCI™ trial will assess clinically relevant bleeding and thrombotic events.
Lead Coordinator: Yvonne Gopsill

S-ICD System Post Approval Study
The S-ICD system is an implantable defibrillator that treats ventricular tachyarrhythmias using a pulse generator and subcutaneous electrode rather than a transvenous lead. The S-ICD Post Approval Study is a non-randomized registry that will retrospectively enroll subjects who participated in the S-ICD Clinical Investigation (IDE G09913) and prospectively enroll new candidates for the S-ICD system. is to document long term safety and effectiveness outcomes associated with the implantation of the SQ-RX pulse generator and Q-TRAK electrode in a commercial clinical setting Data will be collected at implant and annual visits through at least 60 months or study exit.
Lead Coordinator: Cynthia Paysor

A research study of older persons who are admitted to the hospital with a heart attack. Patients will be interviewed in the hospital and again 6 months later. The researchers will also collect detailed medical record information to understand the effect of heart attacks on older persons. The research team at Yale University will use this information to develop a risk model that can be used to help doctors predict recovery. The goal of the study is to help older people in the future make well-informed decisions about their health care during a heart attack.
Lead Coordinator: Diane Bashton

TWILIGHT: Ticagrelor with Aspirin or Alone in High-Risk Patients after Coronary Intervention
The purpose of this study is to compare the use of ticagrelor alone versus ticagrelor and aspirin together. Both ticagrelor and aspirin stop platelets from sticking together and forming a blood clot that could block blood flow to the heart. This study will look to determine the effectiveness and safety of ticagrelor alone, compared to ticagrelor plus aspirin in reducing clinically relevant bleeding and in reducing ischemic adverse events among high-risk patients who have had a percutaneous intervention with at least one drug-eluting stent. A patient is considered high-risk if they meet certain clinical and/or anatomic criteria.
Lead Coordinator:Kyle Mullen

ZILVER® Vena™ Venous Stent (VIVO EU)

This prospective, non-randomized, multi-center study is intended to evaluate the Zilver® Vena™ stent in the treatment of symptomatic iliofemoral venous outflow obstruction. It is a self-expanding, slotted-tube nitinol stent designed to improve luminal diameter in the ileofemoral veins for the treatment of venous outflow obstruction.
Lead Coordinator: Juliet Bala