MyoStrain CMR Testing of Ischemia With Low Levels of Stress

Completed

• Conditions: Myocardial Ischemia; Myocardial Dysfunction; Coronary Artery Disease
• Interventions: Diagnostic Test: MyoStrain

• Registration Number: NCT03543241
• Lead Sponsor: Myocardial Solutions

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 Timeline

• Study Start: 2017-11-08
• Study First Submitted: 2018-05-17
• Study First Submitted QC: 2018-05-31
• Study First Posted: 2018-06-01
• Primary Completion: 2018-09-12
• Study Completion: 2018-10-18
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-15
• Last Update Posted: 2018-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MyoStrain	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.

Primary Outcome Measures

Name	Time	Method
Sensitivity of Ischemic CAD Detection	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 Outcome Measures

Name	Time	Method
Specificity of Ischemic CAD Detection	Up to coronary angiography within 1 month of standard CMR stress testing	Specificity of correctly screening patients with ischemic coronary artery disease based on cardiac catheterization results using MyoStrain stress testing with low dose Dobutamine

Trial Locations

Locations (1)

WakeMed; 🇺🇸 Raleigh, North Carolina, United States