MyoStrain CMR Testing of Ischemia With Low Levels of Stress

Coronary Artery Disease Clinical Trial

Official title:

MyoStrain CMR Testing of Ischemia With Low Levels of Stress

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03543241
• Other study ID #: VAL-1006P(A)
• Status: Completed
• Start date: November 8, 2017
• Est. completion date: October 18, 2018

Study information

• Verified date: December 2018
• Source: Myocardial Solutions
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: October 18, 2018
• Est. primary completion date: September 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Ischemia
• Myocardial Dysfunction
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
United States	WakeMed	Raleigh	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Myocardial Solutions

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Specificity of Ischemic CAD Detection	Specificity of correctly screening patients with ischemic coronary artery disease based on cardiac catheterization results using MyoStrain stress testing with low dose Dobutamine	Up to coronary angiography within 1 month of standard CMR stress testing