Radiofrequency-based Speckle Tracking Echocardiography to Evaluate Diastolic Function

Phase 1

Completed

• Conditions: Heart Failure, Diastolic
• Interventions: Device: Echocardiography system Ultra DCI Model 5000; Device: Echocardiography machine GE Vivid E9; Device: Diastolic function assessment

• Registration Number: NCT01182805
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-08-12
• Study First Submitted QC: 2010-08-16
• Study First Posted: 2010-08-17
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Results First Submitted: 2012-06-25
• Results First Submitted QC: 2012-08-02
• Results First Posted: 2012-08-03
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-02
• Last Update Posted: 2023-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patients scheduled to undergo a clinically indicated left heart cardiac catheterization will be recruited for the study.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm study.	Echocardiography system Ultra DCI Model 5000	-
Single arm study.	Echocardiography machine GE Vivid E9	-
Single arm study.	Diastolic function assessment	-

Primary Outcome Measures

Name	Time	Method
Early Diastolic Mitral Annular Velocity (E-prime) Using Tissue Doppler	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.
Diastolic Circumferential Strain Rate During Isovolumic Relaxation	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.

Trial Locations

Locations (1)

University of Michigan Cardiovascular Center; 🇺🇸 Ann Arbor, Michigan, United States