Radiofrequency-based Speckle Tracking Echocardiography to Evaluate Diastolic Function (RF-SPEED)
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|ClinicalTrials.gov Identifier: NCT01182805|
Recruitment Status : Completed
First Posted : August 17, 2010
Results First Posted : August 3, 2012
Last Update Posted : August 3, 2012
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure, Diastolic||Device: Echocardiography system Ultra DCI Model 5000 Device: Echocardiography machine GE Vivid E9 Device: Diastolic function assessment||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Radiofrequency-based Speckle Tracking Echocardiography to Evaluate Diastolic Function|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2010|
|Single arm study.||
Device: 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.
Device: 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.
Device: 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.
- Diastolic Circumferential Strain Rate During Isovolumic Relaxation [ Time Frame: Assessed from echo obtained at time of enrollment ]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.
- Early Diastolic Mitral Annular Velocity (E-prime) Using Tissue Doppler [ Time Frame: Assessed from echo obtained at time of enrollment ]E-prime is a conventional commonly-used parameter of diastolic function. Higher values of E-prime typically reflect better diastolic function.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01182805
|United States, Michigan|
|University of Michigan Cardiovascular Center|
|Ann Arbor, Michigan, United States, 48109-5853|
|Principal Investigator:||Theodore J Kolias, M.D.||University of Michigan|