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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
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
  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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 20, 2014