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| Name | Class |
|---|---|
| Ottawa Heart Institute Research Corporation | OTHER |
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The purpose of the study is to collect acoustic, ECG, and clinical data from consenting participants, so that AusculSciences can perform analysis on the sounds produced by the heart and determine the accuracy of the CAD-det System for detecting CAD.
This is a prospective multi-center clinical trial. Using the CAD-det, acoustic and electrical cardiac data will be collected from participants with intermediate pretest probability of CAD who are referred to invasive coronary angiography (ICA). The CAD-det recording will be administered prior to the scheduled ICA procedure. The data collected by CAD-det will be processed using AusculSciences' Data Analysis Application (DAA) to produce a patient's indication for CAD.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAD-det | Device | CAD-det test will be done on participants with suspected CAD clinically referred for ICA at a participating clinical investigation site. |
| Measure | Description | Time Frame |
|---|---|---|
| CAD-det to validate: | CAD-det to detect obstructive CAD as defined as QCA diameter stenosis greater than or equal to 50%. | up to 1 Year |
| Measure | Description | Time Frame |
|---|---|---|
| CAD-det to detect: |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Melissa Spero, CRN, CCRP | Contact | 613 763-0088 | 107 | melissa@ausculsciences.com |
| John Phillips, BSc. | Contact | 613 763-0088 | john@ausculsciences.com |
| Name | Affiliation | Role |
|---|---|---|
| Ben Chow, MD | Ottawa Heart Institue Research Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Ottawa Heart Institute | Ottawa | Ontario | K1Y 4W7 | Canada | ||
| University of Ottawa Heart Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23290309 | Background | Makaryus AN, Makaryus JN, Figgatt A, Mulholland D, Kushner H, Semmlow JL, Mieres J, Taylor AJ. Utility of an advanced digital electronic stethoscope in the diagnosis of coronary artery disease compared with coronary computed tomographic angiography. Am J Cardiol. 2013 Mar 15;111(6):786-92. doi: 10.1016/j.amjcard.2012.11.039. Epub 2013 Jan 1. |
| Label | URL |
|---|---|
| Study Sponsor | View source |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D002318 | Cardiovascular Diseases |
| D050197 | Atherosclerosis |
| D054059 | Coronary Occlusion |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D001161 | Arteriosclerosis |
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CAD-det
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| up to 1 year |
| Ottawa |
| Ontario |
| K1Y 4W7 |
| Canada |
|
| D001157 |
| Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |