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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMBIENCE | CADence System testing followed by coronary angiogram |
| |
| AMBIENCE plus R&R Substudy | CADence System testing for repeatibility and reproducibility (4x by 2 operators) followed by coronary angiogram |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CADence | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 hours or discharge from hospital, whichever is sooner |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With CADence-related Adverse Events | 24 hours or discharge from hospital, whichever is sooner |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects already scheduled for coronary angiography who meet study inclusion and exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Carmelo Panetta, MD | University of Minnesota | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart Center Research, LLC | Huntsville | Alabama | 35801 | United States | ||
| MedStar Union Memorial Hospital |
Data will not be shared
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Subjects >40 years of age and scheduled for clinically-indicated angiography were recruited at 3 hospitals across the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | AMBIENCE Study | Participants in the initial AMBIENCE study period |
| FG001 | AMBIENCE Plus R & R | Participants in the AMBIENCE plus Repeatability and Reproducibility portion of the study |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | AMBIENCE Plus R&R Substudy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Count of Participants | Participants | 24 hours or discharge from hospital, whichever is sooner |
Adverse event information was only collected through study exit for each subject (1 day).
All Adverse Events (AEs) and Serious Adverse Events (SAEs) associated with CADence use through discharge were recorded. Those associated with the coronary angiogram and/or subsequent interventions were not collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marie Johnson, PhD | AUM Cardiovascular | 612.799.2511 | mariej@aumcv.com |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Baltimore |
| Maryland |
| 21218 |
| United States |
| St. Joseph's Hospital | Saint Paul | Minnesota | 55102 | United States |
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.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
|
|
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| Secondary | Number of Participants With CADence-related Adverse Events | All participants were assessed and none had adverse events | Posted | Count of Participants | Participants | 24 hours or discharge from hospital, whichever is sooner |
|
|
|
| 0 |
| 70 |
| 0 |
| 70 |
| 0 |
| 70 |
| EG001 | AMBIENCE Plus R&R Substudy | CADence System testing for repeatibility and reproducibility (4x by 2 operators) followed by coronary angiogram CADence System: Obtain CADence data under normal conditions of use for comparison of results with those of coronary angiogram | 0 | 31 | 0 | 31 | 0 | 31 |
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |