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

Overview

Información sobre este estudio

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.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Rochester, Minn.

Investigador principal de Mayo Clinic

Patricia Best, M.D.

Cerrado para la inscripción

More information

Publicaciones

Publications are currently not available
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CLS-20308033

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