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

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 13-000655
    NCT ID: NCT01743040
    Sponsor Protocol Number: 1038-001

About this study

This is a multi-center, prospective, non-randomized, double-blinded trial to evaluate the performance of the CADence device in detecting the existence of clinically significant coronary artery disease.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

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
    • Presence of 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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Patricia Best, M.D.

Closed for enrollment

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CLS-20308033

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