Clinical Evaluation of the CADence Device in Detection of Coronary Artery Diseases

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:

1. Dyslipidemia: LDL >130 mm/dL or HDL <35 mm/dL or on treatment for dyslipidemia

2. Hypertension: blood pressure >140 mmHg systolic, >90 mmHg diastolic or on blood
pressure altering treatment

3. Obesity: BMI>28

4. Current cigarette smoking

5. Diabetes: Type 1 or 2

6. 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 Presence
murmurs including valve lesions, ventricular septal defects, and AV fistualae.

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)
Contraindication to CT angiography

- Renal failure with GFR<50 (angio risk)

- Iodinated contrast allergy

- Elevated heart rate which cannot be controlled sufficiently to achieve a good CT
angiogram

- Body weight >350lbs.

- Sinus rhythm rate greater than 100 beats per minute at screening.

- Atrial fibrillation with average heart rate of greater than 70 beats per minute on
resting screening ECG.