Repeatability and Reproducibility of the CADence™System

Completed

Conditions studied: Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT03793049

Run by

AUM Cardiovascular, Inc.

People needed

79

Starts

2019-01-23

Expected to finish

2019-06-26

Last updated by the study team

2019-07-10

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 910 Medical — Minneapolis, Minnesota, United States
• Northfield Urgent Care Clinic — Northfield, Minnesota, United States
• Pivot Point Medical — Northfield, Minnesota, United States

Full record on ClinicalTrials.gov

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