Back to resultsRadiofrequency-based Speckle Tracking Echocardiography to Evaluate Diastolic Function (RF-SPEED)
Primary Purpose
Heart Failure, Diastolic
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Echocardiography system Ultra DCI Model 5000
Echocardiography machine GE Vivid E9
Diastolic function assessment
Sponsored by
About this trial
This is an interventional diagnostic trial for Heart Failure, Diastolic
Eligibility 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
Sites / Locations
- University of Michigan Cardiovascular Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Single arm study.
Arm Description
Outcomes
Primary Outcome Measures
Diastolic Circumferential Strain Rate During Isovolumic Relaxation
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
E-prime is a conventional commonly-used parameter of diastolic function. Higher values of E-prime typically reflect better diastolic function.
Secondary Outcome Measures
Full Information
NCT ID
NCT01182805
First Posted
August 12, 2010
Last Updated
October 2, 2023
Sponsor
University of Michigan
Collaborators
Pixel Velocity, Inc. / Epsilon Imaging, National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT01182805
Brief Title
Radiofrequency-based Speckle Tracking Echocardiography to Evaluate Diastolic Function
Acronym
RF-SPEED
Official Title
Radiofrequency-based Speckle Tracking Echocardiography to Evaluate Diastolic Function
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Pixel Velocity, Inc. / Epsilon Imaging, National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Diastolic
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single arm study.
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Echocardiography system Ultra DCI Model 5000
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Echocardiography machine GE Vivid E9
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Diastolic function assessment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Diastolic Circumferential Strain Rate During Isovolumic Relaxation
Description
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.
Time Frame
Assessed from echo obtained at time of enrollment
Title
Early Diastolic Mitral Annular Velocity (E-prime) Using Tissue Doppler
Description
E-prime is a conventional commonly-used parameter of diastolic function. Higher values of E-prime typically reflect better diastolic function.
Time Frame
Assessed from echo obtained at time of enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theodore J Kolias, M.D.
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Cardiovascular Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-5853
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Radiofrequency-based Speckle Tracking Echocardiography to Evaluate Diastolic Function
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