Coronary Artery Disease
Conditions
Brief summary
This is a prospective, multi-center study to capture information on sensitivity and specificity of CADence using coronary angiogram as the gold standard, on subjects who are already scheduled for coronary angiography.
Detailed description
CADence is an ECG and acoustic tool to assess coronary artery disease. This study's goal is to collect patient CADence information and compare it to the results of angiogram to determine performance: sensitivity and specificity. The CADence is not used to direct patient care. This is observational only.
Interventions
DEVICECADence
Sponsors
AUM Cardiovascular, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
41 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>40 years * Clinical indication for coronary angiogram * Willing and able to give informed consent
Exclusion criteria
* Body Mass Index (BMI) \<18.5 or \>40 * Prior bypass surgery or coronary stenting * Presence of pacemaker/defibrillator * Presence of artificial valve * Presence of obvious cyanotic or pre-diagnosed congenital heart defect and coarctation of the aorta * Presence of murmurs, including valve lesions, ventricular septal defects and arteriovenous fistulae * Presence of moderate-severe valve disease * 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 or chronic obstructive pulmonary disease (COPD) with active wheezing * Inability to lie in supine position * Heart Transplant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Participants With Positive Agreement of CADence Device Under Normal Use Conditions as Compared to Coronary Angiograms as Accurate and Appropriate | 24 hours or discharge from hospital, whichever is sooner | Angiographically significant stenosis was defined as 70% or greater stenosis in any major coronary artery. Percent of Participants with Positive Agreement of CADence Device Under Normal Use Conditions as Compared to Coronary Angiograms as accurate and appropriate. The study is used to determine two conditions. CADence = Positive for 70% or greater stenosis and CADence = Negative for less than 70% stenosis. The pre-specified intent of this Outcome Measure was to assess all study participants combined, irrespective of whether or not they participated in the Ambience main study or the repeatability and reproducibility sub-study. |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With CADence-related Adverse Events | 24 hours or discharge from hospital, whichever is sooner |
Countries
United States
Participant flow
Recruitment details
Subjects \>40 years of age and scheduled for clinically-indicated angiography were recruited at 3 hospitals across the US.
Participants by arm
| Arm | Count |
|---|---|
| AMBIENCE CADence System testing followed by coronary angiogram
CADence System: Obtain CADence data under normal conditions of use for comparison of results with those of coronary angiogram | 70 |
| AMBIENCE Plus R&R Substudy CADence System testing for repeatability and reproducibility (4x by 2 operators) followed by coronary angiogram
CADence System: Obtain CADence data under normal conditions for comparison of results with those of coronary angiogram.
This part of the study includes patients who are a part of the AMBIENCE study. | 31 |
| Total | 101 |
Baseline characteristics
| Characteristic | Total | AMBIENCE Plus R&R Substudy | AMBIENCE |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 37 Participants | 13 Participants | 24 Participants |
| Age, Categorical Between 18 and 65 years | 64 Participants | 18 Participants | 46 Participants |
| Age, Continuous | 63.60 years STANDARD_DEVIATION 9.56 | 64.65 years STANDARD_DEVIATION 11.14 | 63.14 years STANDARD_DEVIATION 8.82 |
| Race/Ethnicity, Customized Race/Ethnicity Asian | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Black or African American | 18 Participants | 6 Participants | 12 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Other | 4 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White | 78 Participants | 23 Participants | 55 Participants |
| Sex: Female, Male Female | 29 Participants | 6 Participants | 23 Participants |
| Sex: Female, Male Male | 72 Participants | 25 Participants | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 70 | 0 / 31 |
| other Total, other adverse events | 0 / 70 | 0 / 31 |
| serious Total, serious adverse events | 0 / 70 | 0 / 31 |
Outcome results
Primary
Percent of Participants With Positive Agreement of CADence Device Under Normal Use Conditions as Compared to Coronary Angiograms as Accurate and Appropriate
Angiographically significant stenosis was defined as 70% or greater stenosis in any major coronary artery. Percent of Participants with Positive Agreement of CADence Device Under Normal Use Conditions as Compared to Coronary Angiograms as accurate and appropriate. The study is used to determine two conditions. CADence = Positive for 70% or greater stenosis and CADence = Negative for less than 70% stenosis. The pre-specified intent of this Outcome Measure was to assess all study participants combined, irrespective of whether or not they participated in the Ambience main study or the repeatability and reproducibility sub-study.
Time frame: 24 hours or discharge from hospital, whichever is sooner
Population: The Ambience study included a sub-study within the same population. The sub-study was to evaluate the repeatability and reproducibility of the CADence System. Repeatability refers to the ability of the same System operator to obtain the same results each time the same subject is tested with the same System at two points in time. Reproducibility refers to the ability of different operators to obtain the same results when they evaluate the same subjects with either the same or different Systems.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patient CADence Result | Percent of Participants With Positive Agreement of CADence Device Under Normal Use Conditions as Compared to Coronary Angiograms as Accurate and Appropriate | 101 Participants |
| Repeatability and Reproducibility | Percent of Participants With Positive Agreement of CADence Device Under Normal Use Conditions as Compared to Coronary Angiograms as Accurate and Appropriate | 31 Participants |
Secondary
Number of Participants With CADence-related Adverse Events
Time frame: 24 hours or discharge from hospital, whichever is sooner
Population: All participants were assessed and none had adverse events
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patient CADence Result | Number of Participants With CADence-related Adverse Events | Adverse Events | 0 Participants |
| Patient CADence Result | Number of Participants With CADence-related Adverse Events | No adverse events | 101 Participants |