Saving Lives Through Cardiac Research

Our patients gain access to new treatments and technologies before they are available to the general population.

Our experienced team of physicians, researchers and research nurses work closely to incorporate research findings into the comprehensive care of our heart and vascular patients.

Current Studies

ICON RELOADED (International Collaborative of NT-proBNP Re-evaluation of Acute Diagnostic Cut-Offs in the Emergency Department)

This is a prospective multicenter clinical trial to be conducted at up to 20 sites in North America to externally validate the use of Elecsys® proBNP II concentrations to aid in the diagnosis of acutely decompensated heart failure (ADHF) in patients presenting emergently with acute dyspnea, through use of the International Collaborative of NT pro-BNP (ICON) cut-point strategy.

SPONSOR: Roche
Principal Investigator: Dr. Lurie


VOYAGER PAD (Vascular Outcomes Study of ASA along with Rivaroxaban in Endovascular or Surgical Limb Revascularization for Peripheral Artery Disease)

This is an international, multicenter, randomized, double-blind, placebo-controlled phase 3 trial investigating the efficacy and safety of rivaroxaban to reduce the risk of major thrombotic vascular events in patients with symptomatic peripheral artery disease undergoing lower extremity revascularization procedures.

SPONSOR: Bayer HealthCare AG
Principal Investigator: Dr. Chhabra


ARTEMIS (Affordability and Real-world Antiplatelet Treatment Effectiveness after Myocardial Infarction Study)

The ARTEMIS trial is a practical multicenter, cluster-randomized clinical trial that will assess the impact of copayment reduction by equalizing the copayment of clopidrogrel and ticagrelor. ARTEMIS will assess prescribing patterns, patient medication adherence, and clinical outcomes up to one year.

SPONSOR: AstraZeneca
Principal Investigator: Dr. Lurie


CardioMEMS HF System Post Approval Study

This is a prospective, multi-center, open-label trial to evaluate the use of the CardioMEMS HF System in patients with Class III Heart Failure to confirm safety and effectiveness in a commercial setting.

SPONSOR: St. Jude Medical
Principal Investigators: Dr. Shin and Roxanna Balter, NP


SILVER-AMI (Risk Stratification in Older Persons with Acute Myocardial Infarction)

This is 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.

SPONSOR: National Institutes of Health
Principal Investigator: Dr. Lurie


OPEN CTO (Outcomes, Patient Health Status and Efficiency in Chronic Total Occlusion Hybrid Procedures)

This is a prospective, multi-center, observational study. The overall objective of the OPEN CTO Registry is to address current gaps in knowledge regarding chronic total occlusion (CTO) percutaneous coronary intervention (PCI) with five specific aims:

Describe the safety and effectiveness of the Hybrid approach to CTO PCI among patients undergoing elective percutaneous revascularization of native chronic total occlusions.

Quantify the baseline health status effects of CTO among patients selected for CTO PCI and quantify the changes in health status associated with Hybrid approach CTO-PCI.

Describe the predictors of success and failure using the Hybrid approach and evaluate the efficiency of the Hybrid CTO algorithm and its component parts.

Describe the indications and appropriateness of PCI among patients selected for Hybrid approach CTO-PCI.

Describe the cost, cost per Quality Life Year, and hospital contribution margins of Hybrid CTO-PCI.

SPONSOR: Saint Luke's Hospital
Principal Investigator: Dr. Wyman


ABSORB IV

This is a prospective, randomized, single-blind, multi-center study to evaluate the safety and effectiveness of Absorb™ Bioresorbable Vascular Scaffold (BVS)in the treatment of subjects with de novo native coronary artery lesions. ABSORB IV is a continuation of ABSORB III.

SPONSOR: Abbott Cardiovascular Systems, Inc.
Principal Investigator: Dr. Wyman


ABSORB III

This is a prospective, randomized, single-blind, multi-center trial to evaluate the safety and effectiveness of Absorb™ Bioresorbable Vascular Scaffold (BVS)in the treatment of subjects with de novo native coronary artery lesions.

SPONSOR: Abbott Cardiovascular Systems, Inc.
Principal Investigator: Dr. Wyman


ORBIT AF II (Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II)

The ORBIT-AF II registry is a multicenter, prospective registry to evaluate the safety of target-specific oral anticoagulant agents, including FXa inhibitors and direct thrombin inhibitors, in patients with AF.

SPONSOR: Janssen Scientific Affairs, L.L.C
Principal Investigator: Dr. Lurie


EUCLID (Examining Use of Ticagrelor In PAD)

A randomized, double-blind, parallel group, multicenter 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).

SPONSOR: AstraZeneca Pharmaceuticals
Principal Investigator: Dr. Lurie


PIONEER AF-PCI (An Open-label, Randomized, Controlled, Multicenter Study Exploring Two Treatment Strategies of Rivaroxaban and a Dose-Adjusted Oral Vitamin K Antagonist Treatment Strategy in Subjects with Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention)

A study exploring two strategies of rivaroxaban and one of oral vitamin K antagonist (VKA) in patients with atrial fibrillation who undergo percutaneous coronary intervention. The primary purpose of this study is to evaluate the safety for 2 different rivaroxaban treatment strategies and one VKA treatment strategy utilizing various combinations of dual antiplatelet therapy (DAPT) or low-dose aspirin or clopidogrel (or prasugrel or ticagrelor).

SPONSOR: Janssen Scientific Affairs, LLC
Principal Investigator: Dr. Chhabra


ISCHEMIA (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches)

This is an international comparative effectiveness study. Participants will be recruited following clinically indicated stress testing but before catheterization and randomized in a 1:1 fashion to an invasive or optimal medical management strategy. Approximately 8000 participants randomized which will require pre-eligibility screening, CCTA visit, randomization, 1.5 months, 3 months, 6 months, 12 months, and every 6 months thereafter with approximate 4 year follow up.

SPONSOR: National Institutes of Health
Principal Investigator: Dr. Wyman

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