Clinical Evaluation of the CADence Device in Detection of Coronary Artery Diseases
- Conditions
- Coronary Artery Disease
- Interventions
- Diagnostic Test: CADence
- Registration Number
- NCT01743040
- Lead Sponsor
- 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.
- Detailed Description
This is a multi-center, prospective, non-randomized, double-blinded, trial to evaluate the performance of the CADence in detecting the existence of at least one major coronary artery with clinically significant stenosis in a subject is defined as the presence of at least one lesion with ≥ 70% diameter stenosis anywhere in the proximal Left anterior Descending, mid Left anterior Descending, proximal Left Circumflex, mid Left Circumflex , proximal Right Coronary Artery, mid Right Coronary Artery, distal Right Coronary Artery and Obtuse Margin 1, Obtuse Margin 2, and Ramus Intermedius if segment diameter \>2.5 mm or ≥50% diameter stenosis in the Left Main coronary arteries.
Consented subjects will be evaluated with the CADence device and then undergo nuclear stress testing followed by either computed tomography or standard coronary angiography. The maximum expected timeframe between CADence and computed tomography Angiography or standard angiography is 6 weeks.
This is a double-blinded study. All physicians and subjects will be masked to the diagnostic results of the CADence until completion of CADence, nuclear stress, computed tomography or standard coronary angiogram testing for the subjects. Patient care will not be based on the CADence results.
Study participation will conclude after the computed tomography angiography or standard coronary angiography procedure.
computed tomograph or standard coronary angiography are considered acceptable clinical reference standards in this study and are gold standards for detection of coronary artery disease. The experimental unit of this study is the subject. Existence of clinically significant coronary artery disease in a subject is defined as the presence of at least one lesion with ≥ 70% diameter stenosis anywhere in the proximal Left anterior Descending, mid Left anterior Descending, proximal Left Circumflex, mid Left Circumflex, proximal Right Coronary Artery, mid Right Coronary Artery, distal Right Coronary Artery and Obtuse Margin 1, Obtuse Margin 2, and Ramus Intermedius if segment diameter \>2.5 mm or ≥50% diameter stenosis in the Left Main coronary arteries.
The study required sample size is 826 but may enroll up to 1,300 subjects. The sensitivity and specificity of the CADence are expected to be 80% and 73% respectively. Observed sensitivity and specificity will be compared to nuclear stress literature-based performance standards of 83% and 80% respectively using one sample non-inferiority binomial tests with a non-inferiority margin of 15 percentage points. Sample size requirements are 109 subjects with the presence of at least one lesion with ≥ ≥ 70% diameter stenosis anywhere in the proximal Left anterior Descending, mid Left anterior Descending, proximal Left Circumflex, mid Left Circumflex, proximal Right Coronary Artery, mid Right Coronary Artery, distal Right Coronary Artery and Obtuse Margin 1, Obtuse Margin 2, and Ramus Intermedius if segment diameter \>2.5 mm or ≥50% diameter stenosis in the Left MAIN coronary arteries. to test the sensitivity hypothesis and 268 subjects without the presence of at least one lesion with ≥ 70% diameter stenosis anywhere in the proximal Left anterior Descending, mid Left anterior Descending, proximal Left Circumflex, mid Left Circumflex, proximal Right Coronary Artery, mid Right Coronary Artery, distal Right Coronary Artery and Obtuse Margin 1, Obtuse Margin 2, and Ramus Intermedius if segment diameter \>2.5 mm or ≥50% diameter stenosis in the Left MAIN coronary arteries. to test the specificity hypothesis. It was assumed that 15 percent of enrolled subjects would be found to have the presence of at least one lesion with ≥ 70% diameter stenosis anywhere in the proximal Left anterior Descending, mid Left anterior Descending, proximal Left Circumflex, mid Left Circumflex, proximal Right Coronary Artery, mid Right Coronary Artery, distal Right Coronary Artery and Obtuse Margin 1, Obtuse Margin 2, and Ramus Intermedius if segment diameter \>2.5 mm or ≥50% diameter stenosis in the Left Main coronary arteries. In order to accrue 109 subjects with significant Coronary Artery Disease as defined in the protocol, 826 subjects must be enrolled. Sample sizes provide 85% power with alpha of 0.05 for each statistical test.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1014
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description CADence plus CT Angiogram CADence All patients who were not indicated for angiogram due to results of SPECT nuclear stress test underwent CT angiogram CADence plus Standard Angiogram CADence All patients who were indicated for angiogram due to results of SPECT nuclear stress test
- Primary Outcome Measures
Name Time Method Sensitivity and Specificity of CADence to Detect Stenosis Relative to SPECT Performance, Using Either CT or Standard Angiogram as the Gold Standard 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (24)
HealthEast - St. Joseph's Hospital
🇺🇸Saint Paul, Minnesota, United States
Holy Name Medical Center
🇺🇸Teaneck, New Jersey, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Jackson Clinic
🇺🇸Jackson, Tennessee, United States
UCLA
🇺🇸Los Angeles, California, United States
Clearwater Cardiovascular
🇺🇸Clearwater, Florida, United States
Iowa Heart Center
🇺🇸Des Moines, Iowa, United States
Mt. Sinai
🇺🇸New York, New York, United States
Heart Center Research, LLC
🇺🇸Huntsville, Alabama, United States
MedStar Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Cardiology Associates of Mobile
🇺🇸Mobile, Alabama, United States
CentraCare Heart & Vascular Center
🇺🇸Saint Cloud, Minnesota, United States
Lancaster General
🇺🇸Lancaster, Pennsylvania, United States
MedStar Union Memorial Hospital
🇺🇸Baltimore, Maryland, United States
United Heart and Vascular Clinic
🇺🇸Saint Paul, Minnesota, United States
Mercy Hospital
🇺🇸Coon Rapids, Minnesota, United States
Mercy Hospital St. Louis
🇺🇸Saint Louis, Missouri, United States
North Ohio Research
🇺🇸Elyria, Ohio, United States
Columbia University
🇺🇸New York, New York, United States
University of Alabama
🇺🇸Birmingham, Alabama, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Abbott/Minneapolis Heart Institute
🇺🇸Minneapolis, Minnesota, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States