MyoStrain CMR Testing of Ischemia With Low Levels of Stress

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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MyoStrain CMR Testing of Ischemia With Low Levels of Stress

Conditions
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Myocardial Ischemia, Myocardial Dysfunction, Coronary Artery Disease

Intervention / Treatment
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* Diagnostic Test: MyoStrain


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Known or suspected Coronary Artery Disease Symptoms potentially due to CAD; stable angina Positive imaging stress test or negative stress test but typical angina or anginal equivalent Negative Troponin with unstable angina Invasive coronary angiography planned within 3 months of CMR Provided written consent Exclusion Criteria: Pregnancy Contraindication to Magnetic Resonance Imaging Prior allergy to Dobutamine Severe aortic stenosis Hypertrophic Cardiomyopathy Clinically significant Ventricular Tachycardia that would prohibit Dobutamine administration

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MyoStrain<br>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. | Diagnostic Test: MyoStrain<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Strain