Clinical Evaluation of the CADence Device in Detection of Coronary Artery Diseases
TURBULENCE
Pivotal Study of the CADence Device in Detection of Coronary Artery Diseases
1 other identifier
observational
1,014
1 country
24
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2013
Typical duration for all trials
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 4, 2012
CompletedFirst Posted
Study publicly available on registry
December 6, 2012
CompletedStudy Start
First participant enrolled
June 14, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 10, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 10, 2016
CompletedResults Posted
Study results publicly available
July 10, 2020
CompletedJuly 10, 2020
July 1, 2020
2.7 years
December 4, 2012
July 7, 2017
July 9, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sensitivity and Specificity of CADence to Detect Stenosis Relative to SPECT Performance, Using Either CT or Standard Angiogram as the Gold Standard
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.
No more than 3 weeks between CADence, SPECT and standard or CT angiogram
Study Arms (2)
CADence plus Standard Angiogram
All patients who were indicated for angiogram due to results of SPECT 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
Interventions
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.
Eligibility Criteria
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.
You may not qualify if:
- 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: low-density lipoprotein (LDL) \>130 mm/dL or high-density lipoprotein (HDL) \<35 mm/dL or on treatment for dyslipidemia
- Hypertension: blood pressure \>140 millimeter of mercury (mmHg) systolic, \>90 mmHg diastolic or on blood pressure altering treatment
- Obesity: body mass index (BMI)\>28
- Current cigarette smoking
- Diabetes: Type 1 or 2
- Family history: coronary disease in a first or second degree relative
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
University of Alabama
Birmingham, Alabama, 35294, United States
Heart Center Research, LLC
Huntsville, Alabama, 35801, United States
Cardiology Associates of Mobile
Mobile, Alabama, 36608, United States
UCLA
Los Angeles, California, 90502, United States
Hartford Hospital
Hartford, Connecticut, 06102, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Clearwater Cardiovascular
Clearwater, Florida, 33756, United States
Iowa Heart Center
Des Moines, Iowa, 50314, United States
MedStar Union Memorial Hospital
Baltimore, Maryland, 21218, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Abbott/Minneapolis Heart Institute
Minneapolis, Minnesota, 55455, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
CentraCare Heart & Vascular Center
Saint Cloud, Minnesota, 56303, United States
HealthEast - St. Joseph's Hospital
Saint Paul, Minnesota, 55102, United States
United Heart and Vascular Clinic
Saint Paul, Minnesota, 55102, United States
Mercy Hospital St. Louis
St Louis, Missouri, 63141, United States
Holy Name Medical Center
Teaneck, New Jersey, 07666, United States
Columbia University
New York, New York, 10032, United States
Mt. Sinai
New York, New York, 10032, United States
North Ohio Research
Elyria, Ohio, 44035, United States
Lancaster General
Lancaster, Pennsylvania, 17602, United States
Jackson Clinic
Jackson, Tennessee, 38301, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Joseph Thomas, MD
- Organization
- UCLA Biomed
Study Officials
- STUDY CHAIR
Jay Thomas, MD
University of California, Los Angeles
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 4, 2012
First Posted
December 6, 2012
Study Start
June 14, 2013
Primary Completion
February 10, 2016
Study Completion
February 10, 2016
Last Updated
July 10, 2020
Results First Posted
July 10, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share