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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
Current patterns of P2Y12 receptor inhibitor use provide an excellent opportunity to test the impact of co-payment 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.
ClinicalTrials.gov Identifier: NCT02406677
Lead: Juliet Bala – juliet.bala@ahss.org


AUGUSTUS Study Apixaban to Vitamin K Antagonist for the Prevention of Stroke or Systemic Embolism and Bleeding in Patients with Non-valvular Atrial Fibrillation and Acute Coronary Syndrome/Percutaneous Coronary Intervention - BMS
The purpose of this study is to determine if apixaban given for 6 months is safer than Vitamin K Antagonist (VKA) given for 6 months in terms of major bleeding and non-major bleeding in patients with an irregular heart beat (atrial fibrillation) and a recent heart attack or in atrial fibrillation patients undergoing a procedure to open up a blood vessel in the heart (percutaneous coronary intervention). All patients would also be taking a class of medicines called P2Y12 inhibitors (such as clopidogrel). All patients would be treated for an intended 6 months. 
ClinicalTrials.gov Identifier: NCT02415400
Lead:  Cynthia Paysor - cynthia.paysor@ahss.org


DOD - 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 that will compare NIRS, CAC, intracoronary ultrasound (IVUS), and angiographic findings in patients referred for cardiac catheterization as predictors for future cardiac events.  Registered angiographic and IVUS images, as well as NIRS chemograms will be recorded. Patients will subsequently undergo CAC scoring using CT and standard technique as defined in the Prospective Army Coronary Calcium Study (PACC).
Lead: Betsy Szymanski – elizabeth.szymanski@ahss.org


ENABLE MRI Expanding MRI Access for Patients with New & Existing ICDs and CRT-Ds
This study is to collect data to confirm the safety and effectiveness of the ImageReady™ MR Conditional Defibrillation System when used in the 1.5T MRI environment under the labeled Conditions of Use.
ClinicalTrials.gov Identifier: NCT02652481
Lead: Beth Posey - marjorie.haynes@ahss.org


HFaST Development of a Symptom Tracker for Use in Heart Failure
This is a multi-site, cross-sectional, non-interventional, prospective, observational study to be conducted at up to 6 sites within the United States (US). Participants must fulfill all pre-specified entry criteria and must be willing to complete the HFaST for 7 consecutive days following enrollment, as well as complete supporting questionnaires used for the psychometric evaluation of the HFaST.
Study Protocol Number: HEORUSV200388
Lead: Cynthia Paysor – cynthia.paysor@ahss.org


OPTALYSE Optimum Duration of Acoustic Pulse Thrombolysis Procedure in Acute Pulmonary Embolism (OPTALYSE PE)
The objective of the study is to determine the optimum dose of thrombolytic and duration of the ultrasound procedure as a treatment for acute sub massive pulmonary embolism. 
ClinicalTrials.gov Identifier: NCT02396758
Lead: Juliet Bala – juliet.bala@ahss.org


PARACHUTE IV (Percutaneous Ventricular Restoration in Chronic Heart Failure due to Ischemic Heart DiseasE) Trial to Establish Efficacy & 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 NYHA Class III or IV ischemic heart failure. The implantable device, called the Parachute Implant, is a partitioning membrane deployed within the compromised ventricle. This implant Isolates the dysfunctional region of the ventricle and decreases functional chamber volume.  It is intended for use in symptomatic heart failure patients with EF ≤ 35% due to myocardial infarction. 
ClinicalTrials.gov Identifier: NCT01614652
Lead: Cynthia Paysor – cynthia.paysor@ahss.org


PHYSICIAN WELLNESS STUDY
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.  (Dr. Bjornstad - Mary Ostien)
ClinicalTrials.gov Identifier:  NONE
Lead: Peter Bath, D. Min, MBA – peter.bath@ahss.org


QP EXCELS:  Sentus QP - Extended CRT Evaluation With Quadripolar Left Ventricular Leads:  The QP ExCELs study is designed to confirm safety and efficacy of the BIOTRONIK left ventricular leads Sentus OTW QP L and Sentus OTW QP S to satisfy FDA requirements for regulatory approval of the leads in the US.  Long-term safety of the Sentus OTW QP L and Sentus OTW QP S lead will be confirmed during a post approval phase (US sites only). 
ClinicalTrials.gov Identifier: NCT02290028
Lead: Cynthia Paysor – cynthia.paysor@ahss.org


SILVER AMI Outcomes in Older Persons with Heart Attacks
A research study of older persons (≥ 75 years) 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. 
ClinicalTrials.gov Identifier:  NCT01755052
Lead: Cynthia Paysor – cynthia.paysor@ahss.org


TEVA-CDA DREAM:   This Study is to evaluate the Efficacy and Safety of a Allogeneic Mesenchymal Precursor Cells (CEP-41750) for the Treatment of Chronic Heart Failure.
The primary objective of this study is to determine whether trans-endocardial delivery of allogeneic human bone marrow-derived MPCs (CEP-41750) is effective in the treatment of chronic heart failure due to LV systolic dysfunction.  A Double-blind, Randomized, Sham-procedure-controlled, Parallel-group Efficacy and Safety Study of Allogeneic Mesenchymal Precursor Cells (CEP-41750) in Patients With Chronic Heart Failure Due to Left Ventricular Systolic Dysfunction of Either Ischemic or Nonischemic Etiology. 
ClinicalTrials.gov Identifier: NCT02032004
Lead: Betsy Szymanski – elizabeth.szymanski@ahss.org


ZILVER® Vena™ Venous Stent (VIVO EU)
The VIVO Clinical Study is to evaluate the safety and effectiveness of the Zilver® Vena™ Venous Stent in the treatment of symptomatic iliofemoral venous outflow obstruction.
ClinicalTrials.gov Identifier: NCT01970007 
Lead: Juliet Bala – juliet.bala@ahss.org