Radiofrequency-based Speckle Tracking Echocardiography to Evaluate Diastolic Function

Study Overview
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Brief Summary
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The purpose of this study is to evaluate a novel ultrasound system's ability to assess the relaxing properties of the heart compared to current techniques.

Official Title
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Radiofrequency-based Speckle Tracking Echocardiography to Evaluate Diastolic Function

Conditions
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Heart Failure, Diastolic

Intervention / Treatment
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* Device: Echocardiography system Ultra DCI Model 5000
* Device: Echocardiography machine GE Vivid E9
* Device: Diastolic function assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients scheduled to undergo a clinically indicated left heart cardiac catheterization will be recruited for the study. Exclusion Criteria: Suspected acute ST elevation myocardial infarction. Acute coronary syndrome with active ongoing chest pain Known or suspected acute aortic dissection Known or suspected cardiac tamponade Known history of unoperated constrictive pericarditis Known or suspected severe aortic stenosis or severe mitral regurgitation Heart rhythm other than sinus rhythm on pre-cath EKG Age < 18 years old Unable to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single arm study.<br> | Device: Echocardiography system Ultra DCI Model 5000<br>* Each subject will undergo scanning using the investigational echocardiography system (Ultra DCI Model 5000)to measure Diastolic Circumferential Strain Rate during Isovolumic Relaxation (DCSR-IVR) as novel measure of diastolic function.<br>Device: Echocardiography machine GE Vivid E9<br>* Each subject will undergo echocardiography using a conventional echocardiography machine to evaluate the early diastolic mitral annular velocity (E-prime) using tissue Doppler as a standard measure of diastolic function.<br>Device: Diastolic function assessment<br>* Each subject will undergo standard echocardiographic measure of the mitral inflow pattern and invasive catheter-derived measure of left ventricular end-diastolic pressure to determine their diastolic function. This evaluation will be used as the gold standard for this study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diastolic Circumferential Strain Rate During Isovolumic Relaxation | Diastolic circumferential strain rate during isovolumic relaxation is a novel measure of diastolic function that measures the rate of relaxation of the left ventricle during the interval of isovolumic relaxation (the period of active relaxation). We would expect that a higher value reflects better relaxation, and better diastolic function. | Assessed from echo obtained at time of enrollment | 
| Early Diastolic Mitral Annular Velocity (E-prime) Using Tissue Doppler | E-prime is a conventional commonly-used parameter of diastolic function. Higher values of E-prime typically reflect better diastolic function. | Assessed from echo obtained at time of enrollment |