Status:
COMPLETED
Repeatability and Reproducibility of the CADence™System
Lead Sponsor:
AUM Cardiovascular, Inc.
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
22+ years
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 ...
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 book...
Eligibility Criteria
Inclusion
- Subjects clinically indicated for nuclear stress test and who satisfy all the inclusion and exclusion criteria are eligible for participation.
- Inclusion criteria:
- Age 22 years or older
- Willing and able to give informed consent
- Clinical indication for nuclear stress test evaluation
- Chest pain syndrome
- 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
Exclusion
- Subjects clinically indicated for nuclear stress test and who satisfy all the inclusion and exclusion criteria are eligible for participation.
- Inclusion criteria:
- Age 22 years or older
- Willing and able to give informed consent
- Clinical indication for nuclear stress test evaluation
- Chest pain syndrome
- 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
- Exclusion criteria:
- Body Mass Index (BMI)\<18.5 or BMI \>40
- Known coronary disease as defined as:
- Prior bypass surgery or coronary stenting
- Q-wave infarction on a past EKG (\>0.01 sec Q-wave duration in two adjacent leads)
- Presence of pacemaker/defibrillator
- Presence of artificial valve
- Presence of obvious cyanotic or pre-diagnosed congenital heart defect and coarctation of the aorta
- The presence of murmurs including moderate to severe valve disease, ventricular septal defects, and AV fistulae
- Presence of moderate or severe valve disease as defined by \>1/6 heart murmur on physical diagnosis
- Left Ventricular Assist Device (LVAD)
- Presence of scars on the site thorax areas
- Participation in trial within 30 days prior to collecting CADenceTM data except participation in registry studies
- Asthma with wheezing
- Inability to lie flat in the supine position
- Acute coronary syndrome with elevated cardiac biomarkers (TP\>3x upper limit of normal (ULN) or CKMB\>3x ULN)
- Heart transplant
- Current cocaine use (within the past 24 hours, as reported by subject)
- Chronic Obstructive Pulmonary Disease (COPD)
- Patient is not an acceptable candidate for CT angiography:
- Renal failure with GFR \<50
- Iodinated contrast allergy
- Elevated heart rate which cannot be controlled sufficiently to achieve a good CT angiogram
- Body weight \>350lbs
- Persistent sinus rhythm abnormalities (e.g., atrial fibrillation) based on medical history.
Key Trial Info
Start Date :
January 23 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 26 2019
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT03793049
Start Date
January 23 2019
End Date
June 26 2019
Last Update
July 10 2019
Active Locations (3)
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1
910 Medical
Minneapolis, Minnesota, United States, 55455
2
Northfield Urgent Care Clinic
Northfield, Minnesota, United States, 55057
3
Pivot Point Medical
Northfield, Minnesota, United States, 55057