CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 50 enrolled
Drug / intervention
Echocardiography system Ultra DCI Model 5000 +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01182805
NCT01182805Phase 2Completed
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Radiofrequency-based Speckle Tracking Echocardiography to Evaluate Diastolic Function

University of Michigan·interventional·Posted Aug 17, 2010·Updated Oct 16, 2023

In Brief

A Phase 2 clinical trial evaluating Echocardiography system Ultra DCI Model 5000, Echocardiography machine GE Vivid E9, and 1 other intervention for Heart Failure, Diastolic. Completed, enrolled 50 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure, Diastolic
CountriesUnited States
CollaboratorsPixel Velocity, Inc. / Epsilon Imaging, National Heart, Lung, and Blood Institute (NHLBI)

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 17, 2010
Enrollment StartAug 1, 2010
Primary CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 15.9 years ago

Interventions

Echocardiography system Ultra DCI Model 5000device

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 E9device

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 assessmentdevice

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.