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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by AUM Cardiovascular, Inc.
Sponsor:
Information provided by (Responsible Party):
AUM Cardiovascular, Inc.
ClinicalTrials.gov Identifier:
NCT01743040
First received: December 4, 2012
Last updated: August 6, 2014
Last verified: August 2014

December 4, 2012
August 6, 2014
February 2013
December 2014   (final data collection date for primary outcome measure)
Non-inferiority [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01743040 on ClinicalTrials.gov Archive Site
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Clinical Evaluation of the CADence Device in Detection of Coronary Artery Diseases
Pivotal Study of the CADence Device in Detection of Coronary Artery Diseases

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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.

Coronary Artery Disease
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
729
February 2015
December 2014   (final data collection date for primary outcome measure)

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.
Both
22 Years and older
No
United States
 
NCT01743040
1038-001
Yes
AUM Cardiovascular, Inc.
AUM Cardiovascular, Inc.
Not Provided
Study Chair: Jay Thomas, MD University of California, Los Angeles
AUM Cardiovascular, Inc.
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP