MyoStrain CMR Testing of Ischemia With Low Levels of Stress

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03543241

Enrollment

Registered

2018-06-01

Start date

2017-11-08

Completion date

2018-10-18

Last updated

2018-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Myocardial Dysfunction, Myocardial Ischemia

Keywords

Strain

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.

Interventions

DIAGNOSTIC_TESTMyoStrain

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.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026