MyoStrain CMR Testing of Ischemia With Low Levels of Stress
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 13
- Locations
- 1
- Primary Endpoint
- Sensitivity of Ischemic CAD Detection
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Sensitivity of Ischemic CAD Detection
Time Frame: Up to coronary angiography within 1 month of standard CMR stress testing
Sensitivity of correctly identifying ischemic coronary artery disease based on cardiac catheterization results using low dose Dobutamine stress testing with MyoStrain software
Secondary Outcomes
- Specificity of Ischemic CAD Detection(Up to coronary angiography within 1 month of standard CMR stress testing)