Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

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)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (3 locations)

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