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Radiofrequency-based Speckle Tracking Echocardiography to Evaluate Diastolic Function

NCT01182805 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-10-16

Study results available
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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.

Conditions

  • Heart Failure, Diastolic

Interventions

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.

Sponsors & Collaborators

  • Pixel Velocity, Inc. / Epsilon Imaging

    collaborator INDUSTRY

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • University of Michigan

    lead OTHER

Principal Investigators

  • Theodore J Kolias, M.D. · University of Michigan

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01182805 on ClinicalTrials.gov