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MyoStrain CMR Testing of Ischemia With Low Levels of Stress

NCT ID: NCT03543241

Last Updated: 2018-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

13 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-08

Study Completion Date

2018-10-18

Brief Summary

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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

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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

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Coronary Artery Disease Myocardial Ischemia Myocardial Dysfunction

Keywords

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Strain

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

MyoStrain

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Myocardial Solutions

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frances Wood, MD

Role: PRINCIPAL_INVESTIGATOR

WakeMed Health and Hospitals

Locations

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WakeMed

Raleigh, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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VAL-1006P(A)

Identifier Type: -

Identifier Source: org_study_id