Clinical Evaluation of the CADence Device in Detection of Coronary Artery Diseases (TURBULENCE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01743040
Recruitment Status : Completed
First Posted : December 6, 2012
Last Update Posted : July 12, 2016
Information provided by (Responsible Party):
AUM Cardiovascular, Inc.

Brief Summary:
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.

Condition or disease
Coronary Artery Disease

Study Type : Observational
Actual Enrollment : 1054 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pivotal Study of the CADence Device in Detection of Coronary Artery Diseases
Study Start Date : February 2013
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Non-inferiority [ Time Frame: Study completion ]
    Primary endpoints are sensitivity and specificity of the CADence in detecting at least one lesion with ≥70% diameter stenosis anywhere in the pLAD, mLAD pLCx, mLCx, pRCA, mRCA, dRCA and OM1, OM2, and RI if segment diameter >2.5 mm or ≥50% diameter stenosis in the LMAIN coronary arteries.

Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All enrolled subjects that received nuclear stress testing and either CT or standard coronary angiography after the CADence evaluation will be included in the analysis.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01743040

  Show 24 Study Locations
Sponsors and Collaborators
AUM Cardiovascular, Inc.
Study Chair: Jay Thomas, MD University of California, Los Angeles

Responsible Party: AUM Cardiovascular, Inc. Identifier: NCT01743040     History of Changes
Other Study ID Numbers: 1038-001
First Posted: December 6, 2012    Key Record Dates
Last Update Posted: July 12, 2016
Last Verified: July 2016

Keywords provided by AUM Cardiovascular, Inc.:
Coronary Artery Disease
Nuclear Stress Test
CT Angiography

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases