NCT03543241

MyoStrain CMR Testing of Ischemia With Low Levels of Stress

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 13 (actual)
• Sponsor: Myocardial Solutions · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Disease
• Myocardial Ischemia
• Myocardial Dysfunction

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	MyoStrain	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.

Timeline

• Start date: 2017-11-08
• Primary completion: 2018-09-12
• Completion: 2018-10-18
• First posted: 2018-06-01
• Last updated: 2018-12-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study