Cardiology Clinical Trials

PRE-SENSE: Physiological Response to Exercise: Sensor EvaluatioN at Specified Exertions

The goal of the study is to develop device-based, chronic ambulatory sensors that provide clinically relevant diagnostic information to identify the early onset of worsening heart failure. This will be accomplished by evaluating the correlation of specific SRD1 parameters with clinical reference measurements and detailed posture data by comparing the output of the Physiological Response to Activity (PRA) algorithm to the gold standard of CPX testing, as well as to evaluate the repeatability of the measures during activities of daily living over time.

A Phase 3, Open-Label, Multicenter Study for the Assessment of Myocardial Perfusion using Positron Emission Tomography (PET) Imaging of Flurpiridaz F 18 Injection in Patients with Suspected or Known Coronary Artery Disease (CAD)

Lantheus is a research study that will evaluate the flurpiridaz F 18 injection. F 18 is the study imaging agent that contains a small amount of radioactivity and is used to take pictures of the heart using a special camera called a Positron Emission Tomography (PET) scanner. Potential candidates will be asked to participate in this research study because they either have or are suspected of having coronary artery disease (CAD) and have had, or are scheduled to have, a coronary angiogram (also known as a cardiac catheterization). The purpose of this study is to evaluate the use of flurpiridaz F 18 injection (the study imaging agent) in patients with a history of or suspected CAD to determine if flurpiridaz F 18 injection PET imaging is better than the single photon emission computed tomography (SPECT) imaging, which is currently used for this purpose. The safety of flurpiridaz F 18 injection will also be evaluated.

Prospective Multi-center Imaging Study for Evaluation of Chest Pain (PROMISE)

  • Principal Investigator: Andrew Keller, MD
  • Sponsored by National Institute of Health and Duke University

The purpose of this study is to compare different, routinely performed heart tests, such as exercise electrocardiogram (ECG), stress echocardiogram (echo), or stress nuclear test, and coronary computed tomography angiography (CTA), in identifying heart disease and reducing future heart problems. Participants in this research study have symptoms, such as chest pain, which may be from heart disease even if they have no previous history of heart disease. One’s doctor will determine if there is a need for one of these routinely performed heart tests to understand the cause of one’s symptoms. The results from either test will help the doctor determine what type of treatment will be needed. The entire study lasts approximately 5-6 years. Participation will last approximately 2 to 6 years, depending on when one is enrolled. The study will be conducted at about 200-250 different hospitals and medical facilities. About 10,000 people will take part in this study, and up to 1,000 people could take part at Danbury Hospital.

A phase III, double-blind, randomized placebo-controlled study, to evaluate the effects of dalcetrapib on cardiovascular (CV) risk in stable CHD patients, with a documented recent Acute Coronary Syndrome (ACS) (Roche Protocol NC20971)

This study is in the follow-up phase. Participants in this study were selected because there was a chance that they could have a second cardiovascular event. About 15,600 patients are taking part in this research study at multiple sites. This study will last for at least 2 years and up to 5 years.

Renal Optimization Strategies Evaluation in Acute Heart Failure (ROSE –AHF) and Reliable Evaluation of Dyspnea in the Heart Failure Network ROSE Study (RED ROSE)

  • Principal Investigator: Andrew Keller, MD
  • Sponsored by the National National Heart, Lung, and Blood Institute (NHLBI)

Potential participants will be asked to consider this research study because they have been admitted to the hospital with congestive heart failure (a condition in which the heart has difficulty pumping enough blood to the rest of the body) and their kidneys are not working normally. This research study plans to enroll approximately 360 subjects in approximately 9 Regional Clinic Centers and associated satellite centers in the United States and Canada. Participation in this study will last approximately 6 months, which includes follow-up phone calls at 60 days and 6 months from the time you begin participation in the study.

Observational Study Description H7T-US-B007 The TRANSLATE-ACS Study: TReatment with ADP receptor iNhibitorS: Longitudinal Assessment of Treatment Patterns and Events after Acute Coronary Syndrome

Potential candidates will be asked to take part in this research project because they have recently had heart disease and are currently receiving a blood-thinning medication to help keep platelets, which are found in the blood, from sticking together and forming clots that block blood flow (antiplatelet therapy).

This observational study involves the collection of information from patients, and is being coordinated by researchers at Duke Clinical Research Institute (DCRI) who are interested in learning more about the medications used to prevent clot formation given during and after heart disease.

Antiplatelet medications, such as clopidogrel (Plavix) or prasugrel (Effient), are approved treatments that block the function of platelets in the blood, and prevent the formation of clots that could block blood flow to the heart. These medications are often used in patients who have had heart disease and who have undergone a procedure called angioplasty or stenting to open up a blocked artery feeding the heart.

The purpose of this study is to evaluate the effectiveness of these medicines and to examine how doctors prescribe these medications for short- and long-term use. This is an observational study, which means no investigational treatments or procedures will be performed as a result of this study.




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