MyoStrain CMR Testing of Ischemia With Low Levels of Stress

Myocardial Solutions13 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Coronary Artery Disease Myocardial Ischemia Myocardial Dysfunction

Interventions

MyoStrainDIAGNOSTIC_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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

WakeMed

Raleigh, North Carolina, United States

Outcomes

Primary Outcomes

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

Time frame: Up to coronary angiography within 1 month of standard CMR stress testing

Secondary Outcomes

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

Time frame: Up to coronary angiography within 1 month of standard CMR stress testing

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.