Radiofrequency-based Speckle Tracking Echocardiography to Evaluate Diastolic Function

Heart Failure, Diastolic Clinical Trial

— RF-SPEED  

Official title:

Radiofrequency-based Speckle Tracking Echocardiography to Evaluate Diastolic Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01182805
• Other study ID #: RF-SPEED
• Secondary ID: 5R44HL071379
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: August 2010
• Est. completion date: December 2010

Study information

• Verified date: October 2023
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure, Diastolic

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Michigan Cardiovascular Center	Ann Arbor	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
University of Michigan	National Heart, Lung, and Blood Institute (NHLBI), Pixel Velocity, Inc. / Epsilon Imaging

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Assessed from echo obtained at time of enrollment
Primary	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.	Assessed from echo obtained at time of enrollment