Cardiovascular Research

Cardiovascular researchThe LifeBridge Health Cardiovascular Institute strives to provide its patients with the most advanced treatment options available. Groundbreaking research and clinical trials in cardiovascular conditions, testing and treatments are integral to that mission. The treatments available today are derived directly from the willingness of patients to participate in clinical trials.

Goals of clinical trials include testing of the safety and efficacy of new drugs, evaluation of newly developed methods and regimens of treatment, and new approaches to the use of existing treatments.

To learn more about our current research and clinical trials, please call 410-601-8461.


Open Enrollment Trials

Artemis

Mauro Moscucci, M.D.
Affordability and Real-World Antiplatelet Treatment Effectiveness After Myocardial Infarction Study

About: Myocardial infarctions (heart attacks) occur when the heart tissue can't get enough oxygen and dies. Antiplatelet medications are blood-thinning drugs. They help prevent clots from forming and blocking blood flow. These drugs include clopidegrel (Plavix®), ticagrelor (Brillinta®), prasugrel (Effient®). People who have been hospitalized for heart attack and under antiplatelet therapy can be in this study. This study is for Sinai inpatients (patients staying in the hospital) only. Patients in the trial complete questionnaires every three months for about 15 months total. Follow-ups can be over the phone or online. This is an observational study.

Background: Current guidelines for the management of myocardial infarctions, commonly known as heart attacks, recommend treatment with a class of antiplatelet drugs called P2Y12 receptor inhibitors for up to a year after the event. But still, long-term adherence to cardiovascular medications is a problem and disruptions to these treatments have been associated with worse clinical outcomes. In several studies, greater out-of-pocket medications expenses have been associated with more disruptions to treatments. Thus, ARTEMIS will test if patient affordability of these antiplatelet treatments will improve adherence and cardiovascular outcomes for patients.

CONNECTED HEART HEALTH

Mauro Moscucci, M.D.
Connected Heart Health - Heart Failure Readmission Intervention


About: Congestive heart failure is a condition where the heart doesn't pump blood as well as it should. People who have recently been hospitalized for heart failure and have internet access can be in this study. Patients in the trial measure weight, blood pressure and glucose daily and follow CarePlans for improving health. These are tracked by the study team who also notify patients' doctors of important changes. This continues for about six months total.

Background: For health care today, there is a need for better care coordination outside of health care settings between health care providers and patients, especially for patients that are high risk for readmissions and poor health outcomes. Connected Heart Health is the American Heart Association's ACO (Accountable Care Organization) strategy for long-term care outside of the hospital or doctor's office. Evidence-based CarePlans are coordinated with patients for managing heart failure, cardiac rehabilitation, and coronary artery disease. These CarePlans are brought to life with technology enabled by Ambio Health. This study will test the effectiveness of the AHA science based CarePlans and the Ambio Health technology in improving outcomes and health in a real world setting.

RMP

Jeffrey Banker, M.D.
Pilot Study: Resting Membrane Potential of White Blood Cells as an Indicator for Defibrillator Shock


About: Implantable cardioverter defibrillators (ICDs) are devices placed under the skin that shock the heart back to normal heartbeat if abnormal heart rhythms are found. Patients who have had an ICD for more than three years can be in this study. Patients will have the data on their ICDs reviewed and blood drawn one time. There is no more study-related follow-up.

Background: Quite interestingly, many implanted Defibrillator devices never deliver a life-saving shock. A 2008 publication from the New England Journal of Medicine followed 811 Defibrillator patients for a postsurgical period of time. Of these 811 patients using the device for primary prevention therapy, 542 patients (67 percent) received no known Defibrillator shock therapy. This study will test the resting membrane potential of white blood cells from Defibrillator patients and determine if a correlation exists between the value of the resting membrane potential and the appropriate activation (shock) of their Defibrillator. It would be of importance to cardiologists if an altered resting membrane potential in white blood cells, possibly due to a global genetic defect, has a relationship to the activation of the Defibrillator.

UPSTREAM

Ali Tabrizchi, D.O.
Utilization of Ticagrelor in the Upstream Setting for Non-ST-Segment Elevation Acute Coronary Syndrome: An ED-Based Clinical Registry


About: Myocardial infarctions (heart attacks) occur when the heart tissue can't get enough oxygen and dies. Antiplatelet medications are blood thinning drugs. They help prevent clots from forming and blocking blood flow. These drugs include clopidegrel (Plavix®), ticagrelor (Brillinta®), prasugrel (Effient®). People who have been hospitalized for heart attack and under antiplatelet therapy can be in this study. This study is for Sinai inpatients (patients staying in the hospital) only. Patients in the study will have data collected from hospital stay. Patients who were prescribed ticagrelor (Brilita®) will have one follow-up phone call about 30 days after they leave the hospital. This is an observational study.

Background: Heart attacks are categorized by the ST-segment on the ECG (electrocardiography): non-ST-Segment-elevation-Myocardial-Infarctions (NSTEMls) and ST-Segment-Elevation-Myocardial-Infarction (STEMls). The ST-segment indicates more severe, full thickness damage of cardiac muscle compared to the partial thickness damage of NSTEMI. Medical care of patients with non-ST-segment elevation myocardial infarction (NSTEMI) who are invasively managed can be divided into two phases: "upstream" and "downstream." The upstream interval encompasses all care provided prior to diagnostic angiography. Specifically, a knowledge gap exists with regards to details of the course of treatment for patients with NSTEMI between emergency department (ED) arrival and diagnostic angiography. The UPSTREAM registry aims to address this data gap and to test if the use of upstream ticagrelor is associated with a smooth transition of care into the outpatient setting.

WRAP-IT

Paresh Shah, M.D.
Worldwide Randomized Antibiotic Envelope Infection Prevention Trial


About: Cardiac Implantable Electronic Devices (CIEDs) are devices placed under the skin to correct abnormal heart rhythms. Patients who are planning to undergo a CIED procedure can be in this study. Patients will have their CIED placed with an antibacterial envelope or no envelope. Patients will be followed up every six months by office visit or phone call until one year after the last patient enters the study.

Background: CIED infections result in significant financial burden for patients, hospitals and third-party payers, including prolonged hospitalization, prolonged antibacterial treatment, management of systemic complications of sepsis, and costs involved in device extraction and possible re-implantation. Over the last two decades, the in-hospital charges for CIED infection increased by almost 100 percent. Among a large cohort of Medicare patients who were admitted for CIED generator implantation, replacement or revision, CIED infection increased the cost by 1.4 to 1.8 fold depending on the type of CIED. Intensive care hospitalization accounted for more than 40 percent of the incremental costs. Cost ratios with ICD infection appeared to be substantially higher than with JPG infection. The TYRX Antibacterial envelope is designed to hold a CIED to create a stable environment when implanted in the body. The study will test if the rate of major CIED infections through 12-months post-procedure decreases with the TYRX envelope group compared to the control group (no TYRX envelope).


Closed Enrollment Trials

ORBIT AF-II

Jeffrey Banker, M.D.
Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II


ORBIT AF-II

Chaitanya Ravi, M.D.
Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II