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Radiofrequency-based Speckle Tracking Echocardiography to Evaluate Diastolic Function (RF-SPEED)

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT01182805
First received: August 12, 2010
Last updated: August 2, 2012
Last verified: August 2012
History of Changes
  Purpose

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 Intervention 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
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Radiofrequency-based Speckle Tracking Echocardiography to Evaluate Diastolic Function

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Diastolic Circumferential Strain Rate During Isovolumic Relaxation [ Time Frame: Assessed from echo obtained at time of enrollment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    E-prime is a conventional commonly-used parameter of diastolic function. Higher values of E-prime typically reflect better diastolic function.


Enrollment: 50
Study Start Date: August 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01182805

Locations
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
Principal Investigator: Theodore J Kolias, M.D. University of Michigan
  More Information

No publications provided

Responsible Party: Theodore J. Kolias, Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01182805     History of Changes
Other Study ID Numbers: RF-SPEED, 5R44HL071379
Study First Received: August 12, 2010
Results First Received: June 25, 2012
Last Updated: August 2, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Heart Failure
Heart Failure, Diastolic
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 17, 2012