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The purpose of the study is to evaluate the effectiveness of the CADence system, a non-invasive device, in detecting greater than or equal to 50% coronary stenosis anywhere in the coronary tree.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CADence System | Device | Non-invasive detection of > or equal to 50% stenosis in any of the major coronary arteries. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of CADence in detecting greater than or equal to 50% stenosis anywhere in the coronary tree. | The CADence System will be considered to have demonstrated effectiveness in detecting greater than or equal to 50% coronary artery stenosis anywhere in the coronary tree if the estimated sensitivity as compared to angiography is statistically higher than 70%. | within three months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Wilson, MD | University of Minnesota | Study Chair |
| Roxana Mehran, MD | Mt. Sinai | Study Chair |
| James Chapman, MD | Cheyenne Vascular & Heart Institute | Principal Investigator |
| Mark Tannenbaum, PhD | Iowa Heart Center | Principal Investigator |
| Robert Schwartz, MD | Abbott/Minneapolis Heart Institute | Principal Investigator |
| Jeff Chambers, MD | Mercy Hospital | Principal Investigator |
| Giora Weisz, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Iowa Heart Center | Des Moines | Iowa | 50314 | United States | ||
| Mercy Hospital |
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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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| Coon Rapids |
| Minnesota |
| 55433 |
| United States |
| Abbott/Minneapolis Heart Institute | Minneapolis | Minnesota | 55455 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Columbia University | New York | New York | 10032 | United States |
| Mt. Sinai | New York | New York | 10032 | United States |
| Cheyenne Vascular & Heart Institute | Cheyenne | Wyoming | 82001 | United States |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |