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This prospective, observational study evaluates the accuracy of stress testing with the MyoStrain SENC CMR Imaging System to detect myocardial ischemia and viability in patients with suspected coronary artery disease using low levels of stress.
This prospective, single center study evaluates the MyoStrain SENC CMR Imaging System for the detection of myocardial ischemia and viability during conventional Cardiac Magnetic Resonance (CMR) wall motion stress testing. Patients with known or suspected coronary artery disease and scheduled for cardiac catheterization will be consented for inclusion in the study and evaluated during stress testing with low dose Dobutamine as the stressor agent. Data obtained with the MyoStrain SENC CMR Imaging System will be for observational purposes and will not be used to alter patient management.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MyoStrain | Patients with suspected CAD and scheduled for cardiac catheterization will receive traditional CMR wall motion stress testing with MyoStrain software analysis of myocardial ischemia and viability. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MyoStrain | Diagnostic Test | Prior to cardiac catheterization, patients will be stress testing with low dose Dobutamine to evaluate wall motion, segmental, and global myocardial strain at rest and under stress to determine the accuracy of detecting ischemia and viability of myocardial tissue. |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of Ischemic CAD Detection | Sensitivity of correctly identifying ischemic coronary artery disease based on cardiac catheterization results using low dose Dobutamine stress testing with MyoStrain software | Up to coronary angiography within 1 month of standard CMR stress testing |
| Measure | Description | Time Frame |
|---|---|---|
| Specificity of Ischemic CAD Detection | Specificity of correctly screening patients with ischemic coronary artery disease based on cardiac catheterization results using MyoStrain stress testing with low dose Dobutamine | Up to coronary angiography within 1 month of standard CMR stress testing |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with known or suspected coronary artery disease scheduled for cardiac catheterization.
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| Name | Affiliation | Role |
|---|---|---|
| Frances Wood, MD | WakeMed Health and Hospitals | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WakeMed | Raleigh | North Carolina | 27610 | United States |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D017202 | Myocardial Ischemia |
| D013180 | Sprains and Strains |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
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|
| D001157 |
| Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D014947 | Wounds and Injuries |