MyoStrain CMR Testing of Ischemia With Low Levels of Stress

NCT03543241 | Completed FDA Device

• 1 other identifier: VAL-1006P(A)
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Myocardial Ischemia; Myocardial Dysfunction

Keywords

Strain

Outcome Measures

Primary Outcomes (1)

• 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

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

Secondary Outcomes (1)

• Specificity of Ischemic CAD Detection

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

Study Arms (1)

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.

Diagnostic Test: MyoStrain

Interventions

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.

MyoStrain

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with known or suspected coronary artery disease scheduled for cardiac catheterization.

You may qualify if:

• 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

You may not qualify if:

• Pregnancy
• Contraindication to Magnetic Resonance Imaging
• Prior allergy to Dobutamine
• Severe aortic stenosis
• Hypertrophic Cardiomyopathy
• Clinically significant Ventricular Tachycardia that would prohibit Dobutamine administration

Sponsors & Collaborators

• Myocardial Solutions: lead

Study Sites (1)

WakeMed

Raleigh, North Carolina, 27610, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Ischemia; Sprains and Strains

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Wounds and Injuries

Study Officials

• Frances Wood, MD

  WakeMed Health and Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2018
• First Posted: June 1, 2018
• Study Start: November 8, 2017
• Primary Completion: September 12, 2018
• Study Completion: October 18, 2018
• Last Updated: December 19, 2018

Record last verified: 2018-12

Locations

US (1)