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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
Sponsor:
Collaborators:
Pixel Velocity, Inc. / Epsilon Imaging
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Theodore J. Kolias, University of Michigan

Study Description
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Brief Summary:
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.

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Michigan
University of Michigan Cardiovascular Center
Ann Arbor, Michigan, United States, 48109-5853
Sponsors and Collaborators
University of Michigan
Pixel Velocity, Inc. / Epsilon Imaging
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Theodore J Kolias, M.D. University of Michigan
More Information
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Responsible Party: Theodore J. Kolias, Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01182805    
Other Study ID Numbers: RF-SPEED
5R44HL071379 ( U.S. NIH Grant/Contract )
First Posted: August 17, 2010    Key Record Dates
Results First Posted: August 3, 2012
Last Update Posted: August 3, 2012
Last Verified: August 2012
Additional relevant MeSH terms:
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Heart Failure, Diastolic
Heart Failure
Heart Diseases
Cardiovascular Diseases