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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.
 
ClinicalTrials.gov Identifier: NCT01743040
Recruitment Status : Completed
First Posted : December 6, 2012
Results First Posted : July 10, 2020
Last Update Posted : July 10, 2020
Sponsor:
Information provided by (Responsible Party):
AUM Cardiovascular, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment
Coronary Artery Disease Diagnostic Test: CADence

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Study Type : Observational
Actual Enrollment : 1014 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pivotal Study of the CADence Device in Detection of Coronary Artery Diseases
Actual Study Start Date : June 14, 2013
Actual Primary Completion Date : February 10, 2016
Actual Study Completion Date : February 10, 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
CADence plus Standard Angiogram
All patients who were indicated for angiogram due to results of SPECT nuclear stress test
Diagnostic Test: CADence

Patients with chest pain and two or more coronary risk factors and who were already indicated for nuclear stress test were enrolled in the study. The CADence was performed prior to nuclear stress test. Patients underwent standard angiogram based upon normal clinical judgement. In all other patients a CT angiogram followed.

CADence is a handheld equipped with acoustic sensor technology, a patient booklet, remote algorithm and final report.

Other Names:
  • CT Angiogram
  • Angiogram
  • Nuclear Stress Test

CADence plus CT Angiogram
All patients who were not indicated for angiogram due to results of SPECT nuclear stress test underwent CT angiogram
Diagnostic Test: CADence

Patients with chest pain and two or more coronary risk factors and who were already indicated for nuclear stress test were enrolled in the study. The CADence was performed prior to nuclear stress test. Patients underwent standard angiogram based upon normal clinical judgement. In all other patients a CT angiogram followed.

CADence is a handheld equipped with acoustic sensor technology, a patient booklet, remote algorithm and final report.

Other Names:
  • CT Angiogram
  • Angiogram
  • Nuclear Stress Test




Primary Outcome Measures :
  1. Sensitivity and Specificity of CADence to Detect Stenosis Relative to SPECT Performance, Using Either CT or Standard Angiogram as the Gold Standard [ Time Frame: No more than 3 weeks between CADence, SPECT and standard or CT angiogram ]
    The CADence will be considered to have demonstrated effectiveness in detecting the presence of at least one lesion with ≥ 70% diameter stenosis anywhere in the proximal Left anterior Descending (pLAD), mid Left anterior Descending (mLAD), proximal Left Circumflex (pLCx), mid Left Circumflex (mLCx), proximal Right Coronary Artery (pRCA), mid Right Coronary Artery (mRCA), distal Right Coronary Artery (dRCA) and Obtuse Margin 1 (OM1), Obtuse Margin 2 (OM2), and Ramus Intermedius (RI) if segment diameter >2.5 mm or ≥50% diameter stenosis in the Left Main coronary arteries if sensitivity and specificity are non-inferior within 15 percentage points to a sensitivity of 83% and a specificity of 80%, which is the literature-based Objective Performance Criteria (OPC) for nuclear stress tests.



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.
Criteria

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: low-density lipoprotein (LDL) >130 mm/dL or high-density lipoprotein (HDL) <35 mm/dL or on treatment for dyslipidemia
  2. Hypertension: blood pressure >140 millimeter of mercury (mmHg) systolic, >90 mmHg diastolic or on blood pressure altering treatment
  3. Obesity: body mass index (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 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).

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 ClinicalTrials.gov identifier (NCT number): NCT01743040


Locations
Show Show 24 study locations
Sponsors and Collaborators
AUM Cardiovascular, Inc.
Investigators
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Study Chair: Jay Thomas, MD University of California, Los Angeles
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Responsible Party: AUM Cardiovascular, Inc.
ClinicalTrials.gov Identifier: NCT01743040    
Other Study ID Numbers: 1038-001
First Posted: December 6, 2012    Key Record Dates
Results First Posted: July 10, 2020
Last Update Posted: July 10, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by AUM Cardiovascular, Inc.:
Coronary Artery Disease
Nuclear Stress Test
CT Angiography
Angiography
CADence
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases