Coronary Artery Disease
Conditions
Keywords
acoustic, ECG
Brief summary
This study is designed as a prospective study to capture data for evaluating the repeatability and reproducibility of the CADence™ System. The study will be conducted at 3 different study sites using 6 CADence™ systems. Each subject will be tested 4 separate times by 2 different operators at each site and will be tested at all 3 site locations in order to accomplish this evaluation. The study will enroll a total of at least 24 CADence positive patients and at least 24 CADence negative patients.
Detailed description
The CADence™ system is comprised of a digital stethoscope used to record cardiac (heart) sounds, with integrated sensor used to record electrical activity of the heart (ECG), a single-use patient booklet, and the CADence™ Software application. CADence™ Software is a clinical decision support tool for the noninvasive functional evaluation of patients presenting with chest pain and at least two coronary artery disease risk factors that is intended to aid a qualified clinician's analysis of normal/physiological and pathological heart murmurs and in ruling out significant coronary disease as a cause for these symptoms of cardiovascular disease, utilizing simultaneous recording of cardiac sounds and ECG. The purpose of this study is to assess the precision of the CADence site using multiple operators, cadence systems and clinical sites.
Interventions
DEVICECADence testing will be performed
CADence is a noninvasive, handheld device comprised of acoustic and ECG technology and software
Sponsors
AUM Cardiovascular, Inc.
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects clinically indicated for nuclear stress test and who satisfy all the inclusion and
Exclusion criteria
are eligible for participation. Inclusion criteria: 1. Age 22 years or older 2. Willing and able to give informed consent 3. Clinical indication for nuclear stress test evaluation 4. Chest pain syndrome 5. Two or more coronary artery disease risk factors as defined by: * Dyslipidemia: LDL \>130 mm/dL or HDL \<35 mm/dL or on treatment for dyslipidemia * Hypertension: blood pressure \>140 mmHg systolic, \>90 mmHg diastolic or on blood pressure altering treatment * Obesity: BMI\>28 * Current cigarette smoking * Diabetes: Type 1 or 2 * Family history: coronary disease in a first or second degree relative
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positive Percent Agreement and Negative Percent Agreement | 14 days | repeatability and reproducibility |
Countries
United States
Outcome results
None listed