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

Completed

Conditions studied: Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT01743040

Run by

AUM Cardiovascular, Inc.

People needed

1014

Starts

2013-06-14

Expected to finish

2016-02-10

Last updated by the study team

2020-07-10

Who can join

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

You may qualify if…

• 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) <35 mm/dL or on treatment for dyslipidemia
• Hypertension: blood pressure >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

You may not qualify if…

• 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 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)<50 (angio risk)
• Iodinated contrast allergy
• Elevated heart rate which cannot be controlled sufficiently to achieve a good computed tomography 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 electrocardiogram (ECG).

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• Heart Center Research, LLC — Huntsville, Alabama, United States
• Cardiology Associates of Mobile — Mobile, Alabama, United States
• UCLA — Los Angeles, California, United States
• Hartford Hospital — Hartford, Connecticut, United States
• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
• Clearwater Cardiovascular — Clearwater, Florida, United States
• Iowa Heart Center — Des Moines, Iowa, United States
• MedStar Union Memorial Hospital — Baltimore, Maryland, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Mercy Hospital — Coon Rapids, Minnesota, United States
• Abbott/Minneapolis Heart Institute — Minneapolis, Minnesota, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• CentraCare Heart & Vascular Center — Saint Cloud, Minnesota, United States
• HealthEast - St. Joseph's Hospital — Saint Paul, Minnesota, United States
• United Heart and Vascular Clinic — Saint Paul, Minnesota, United States
• Mercy Hospital St. Louis — St Louis, Missouri, United States
• Holy Name Medical Center — Teaneck, New Jersey, United States
• Columbia University — New York, New York, United States
• Mt. Sinai — New York, New York, United States
• North Ohio Research — Elyria, Ohio, United States
• Lancaster General — Lancaster, Pennsylvania, United States
• Jackson Clinic — Jackson, Tennessee, United States

Full record on ClinicalTrials.gov

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