N/A N=1,014

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

Coronary Artery Disease

Bottom Line

View on ClinicalTrials.gov: NCT01743040 ↗

Enrolled (actual)

1,014

Serious AEs

0.8%

Results posted

Jul 2020

Primary outcome: Primary: Sensitivity and Specificity of CADence to Detect Stenosis Relative to SPECT Performance, Using Either CT or Standard Angiogram as the Gold Standard — 78; 36 percent — p=0.012

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: CADence (Diagnostic_test)
Age: Adult, Older Adult · 22+ yrs
Sex: All
Sponsor: AUM Cardiovascular, Inc.
Primary completion: Feb 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Sensitivity and Specificity of CADence to Detect Stenosis Relative to SPECT Performance, Using Either CT or Standard Angiogram as the Gold Standard	78; 36	0.012 sig

Summary

This is a multi-center, prospective, non-randomized, double-blinded trial to evaluate the sensitivity and specificity of the CADence device in detecting the existence of clinically significant coronary artery disease as determined by either standard or CT angiography.

Eligibility Criteria

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: low-density lipoprotein (LDL) >130 mm/dL or high-density lipoprotein (HDL) 140 millimeter of mercury (mmHg) systolic, >90 mmHg diastolic or on blood pressure altering treatment
Obesity: body mass index (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) 40

Known coronary disease as defined as:

Prior bypass surgery or coronary stenting Q-wave infarction on a past electrocardiogram (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 arteriovenous (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 CADence data except participation in registry studies Asthma with wheezing Inability to lie flat in the supine position Acute coronary syndrome with elevated cardiac biomarkers (troponin (TP)>3x upper limit of normal (ULN) or creatine kinase MB (CKMB) >3x ULN) Heart Transplant Current cocaine use (within the past 24 hours, as reported by subject) Chronic Obstructive Pulmonary Disease (COPD) Contraindication to computed tomography (CT) angiography

Renal failure with glomerular filtration rate (GFR) 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 electrocardiogram (ECG).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01743040). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.