Treatment Trials

14 Clinical Trials for Various Conditions

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COMPLETED
Development of an Algorithm to Differentiate Heart Murmurs Using Electronic Stethoscopes
Description

The Eko CORE and DUO stethoscopes are FDA-approved electronic devices that have the capacity to record heart sounds. The study seeks to expand murmur detection to include VHD classification through the development of novel ML algorithms that are able to distinguish between systolic vs. diastolic vs. continuous murmurs, as well as classify VHD type and severity, using 4-point auscultation with Eko CORE and DUO electronic stethoscopes to record heart sounds.

RECRUITING
EKO SENSORA: Detecting Clinically Significant Murmurs
Description

The Eko Artificial Intelligence (AI) has primarily been evaluated in the primary care setting. The digital stethoscope records a phonocardiogram of heart sounds of the patient and uses machine learning artificial intelligence to identify if there are abnormalities present (Eko Health, 2023). The Eko SENSORA will be tested in the emergency department. Chest pain, fatigue, shortness of breath and syncope are all symptoms that could indicate a cardiac dysfunction. The hypothesis is that this device will allow us increased ability to detect valvular heart disease that is clinically significant.

Conditions
COMPLETED
: A Prospective Study Investigating the Use of the Eko CORE and Eko DUO Electronic Stethoscopes in Pediatric Patients.
Description

The Eko CORE and DUO stethoscopes are FDA approved electronic devices which have the capacity to record heart sounds. This study will utilize these devices to see if they can differentiate between pathologic and innocent heart murmurs in children.

Conditions
COMPLETED
Study of Two Teaching Techniques to Teach Cardiac Auscultation to Physicians
Description

Our objective was to test two educational interventions for teaching cardiac auscultation: self-directed learning using portable audio files versus a single, massed multimedia lecture intervention similar to current best practice, to determine which would most effectively increase recognition of common cardiac sounds by physicians. The investigators hypothesized that doctors learning on their own time could better improve their skills.

Conditions
COMPLETED
The Accuracy of an Artificially-intelligent Stethoscope
Description

This study will characterize the accuracy of a commercially available artificially-intelligent stethoscope in determining which childhood murmurs suggest underlying congenital structural heart disease and therefore warrant diagnostic echocardiograms.

COMPLETED
Real-World Evaluation of Eko Algorithms in a Point of Care Setting
Description

The purpose of this research is to prospectively test and validate the utility of Eko artificial intelligence (AI) plus Eko Murmur Analysis Software (EMAS) murmur characterization in algorithm in a real world, point-of-care setting.

TERMINATED
Real-World Evaluation of Eko Murmur Analysis Software in a Point of Care Setting
Description

The purpose of this research is to evaluate the impact of Eko AI plus EMAS (Eko Murmur Analysis Software) on a clinician's referral decision in a real-world primary care setting. There is an additional objective of understanding patient outcomes when patients are referred for cardiology follow-up and/or echocardiogram.

WITHDRAWN
Rapid Non-invasive Detection of Aortic Stenosis
Description

Avicena is developing new non-invasive methods (hardware and software) for diagnosis of a variety of heart conditions. This study is designed to compare data obtained using Avicena's device, the Vivio, to data obtained from transthoracic echocardiography (TTE) for the diagnosis of moderate-to-severe aortic stenosis. Aortic stenosis (AS) is a disease of the valve (aortic valve) that separates the left ventricle of the heart from the aorta. When AS is severe, the heart cannot pump adequate amounts of blood into the arterial tree. AS is often silent until the disease is severe. This study compares a rapid test using Vivio to a longer and more expensive test that is the current gold standard for diagnosis of AS, TTE.

COMPLETED
Phono- and Electrocardiogram Assisted Detection of Valvular Disease
Description

The diagnosis of valvular heart disease (VHD), or its absence, invariably requires cardiac imaging. A familiar and inexpensive tool to assist in the diagnosis or exclusion of significant VHD could both expedite access to life-saving therapies and reduce the need for costly testing. The FDA-approved Eko Duo device consists of a digital stethoscope and a single-lead electrocardiogram (ECG), which wirelessly pairs with the Eko Mobile application to allow for simultaneous recording and visualization of phono- and electrocardiograms. These features uniquely situate this device to accumulate large sets of auscultatory data on patients both with and without VHD. In this study, the investigators seek to develop an automated system to identify VHD by phono- and electrocardiogram. Specifically, the investigators will attempt to develop machine learning algorithms to learn the phonocardiograms of patients with clinically important aortic stenosis (AS) or mitral regurgitation (MR), and then task the algorithms to identify subjects with clinically important VHD, as identified by a gold standard, from naïve phonocardiograms. The investigators anticipate that the study has the potential to revolutionize the diagnosis of VHD by providing a more accurate substitute to traditional auscultation.

TERMINATED
Retrospective Evaluation of Carvedilol Versus Captopril in CHF Patients
Description

This is a retrospective chart review examining our experience with carvedilol in CHF secondary to left-to-right heart shunt lesions. The treatment group will be children who have received carvedilol. The control or comparison groups will be patients who have received either digoxin/furosemide or captopril for this indication. Charts will be reviewed of patients who have been treated at Children's Healthcare of Atlanta and as outpatients by Sibley Heart Center Cardiology between September 2000 and October 2005. Patients will have been started on carvedilol prior to April 1, 2005 and only information up to October 1, 2005 will be used for this study. We will review approximately 50 charts for this study. We will evaluate the effectiveness of these medications at reducing symptoms of CHF.

TERMINATED
Effect of Dronedarone on Atrial Fibrosis Progression and Atrial Fibrillation Recurrence
Description

Patients who have undergone cardiac ablation will be randomized and blinded to one of two groups; one group will receive dronedarone while the other group will receive a placebo. The incidence of atrial fibrillation recurrence, as well as atrial fibrosis progression, will be analyzed between the two trial groups.

RECRUITING
Tulane iPredict, Prevent Study to Evaluate the Progression of Atrial Myopathy.
Description

To evaluate the progression of atrial myopathy through wearable devices and cardiac imaging.

COMPLETED
Understanding Pediatric Chest Pain and Other Symptoms
Description

The causes of pediatric pain are often not the same for every child. Most children who visit a cardiology specialist with complaints of chest or other somatic pain have no known medical diagnosis to explain their symptoms. These children and their families often leave with no explanation for the child's distress. This early study will ask parents and children specific questions related to the stress in their lives, their emotional well-being and the children's physical functioning. The investigators want children who experience chest and other somatic pain, and those who do not, to be in their study so that they can look at both groups. The investigators hope to use these answers to better inform cardiologists who often work with children with non-cardiac pain and, in turn, help them to better serve their patients. Ultimately, the investigators hope that the answers they get will provide answers to these families. They also hope to use the results of this study to put together a short screener for the cardiologist to give to pediatric patients with complaints of chest or other somatic pain to help the cardiologists better understand their patients' symptoms.

Conditions
UNKNOWN
Perry Virtual - A Prospective and Observational Rural Health Trial
Description

The principal objective of the study is to determine if patient-empowered, real-time and home- based patient monitoring of vital parameters can lead to: * Reduction in admission rates and improved clinical management of chronically ill patients * Reduction in use of medications * Reported quality of life A minimum of 100 patients will be recruited, monitored and observed over 6 months from home with the Coala Heart Monitor. The study population will be representative of rural, high-risk, Medicare (65+ of age) subjects with chronic conditions and will be recruited by the Perry Community Hospital in Linden, TN.