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Completed

NCT Number: NCT03543241

MyoStrain CMR Testing of Ischemia With Low Levels of Stress

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Dysfunction Myocardial Ischemia Sprains and Strains Vascular Diseases Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

WakeMed

Raleigh, North Carolina, 27610, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MyoStrain

Diagnostic 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.

Primary outcomes

  1. Sensitivity of Ischemic CAD Detection

    Time frame: 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 outcomes

  1. Specificity of Ischemic CAD Detection

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Myocardial Solutions

Industry

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 1, 2018
Registry last updated
Dec 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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