MyoStrain CMR Testing of Ischemia With Low Levels of Stress

Myocardial Solutions

Status: Completed

Conditions: Coronary Artery Disease; Myocardial Ischemia; Myocardial Dysfunction

Treatments: Diagnostic Test: MyoStrain

Study type: Observational

Funder types: Industry

Identifiers

NCT03543241

VAL-1006P(A)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

13 participants in 1 patient group

MyoStrain

Description:

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.

Treatment:

Diagnostic Test: MyoStrain