Radiofrequency-based Speckle Tracking Echocardiography to Evaluate Diastolic Function
NCT ID: NCT01182805
Last Updated: 2023-10-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
50 participants
INTERVENTIONAL
2010-08-31
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Single arm study.
Echocardiography system Ultra DCI Model 5000
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.
Echocardiography machine GE Vivid E9
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.
Diastolic function assessment
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.
Interventions
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Echocardiography system Ultra DCI Model 5000
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.
Echocardiography machine GE Vivid E9
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.
Diastolic function assessment
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Pixel Velocity, Inc. / Epsilon Imaging
INDUSTRY
National Heart, Lung, and Blood Institute (NHLBI)
NIH
University of Michigan
OTHER
Responsible Party
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Theodore J. Kolias
Associate Professor
Principal Investigators
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Theodore J Kolias, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Michigan Cardiovascular Center
Ann Arbor, Michigan, United States
Countries
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Other Identifiers
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RF-SPEED
Identifier Type: -
Identifier Source: org_study_id
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