Integrated RF and B-mode Deformation Analysis for 4D Stress Echocardiography

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02327455

Enrollment

Registered

2014-12-30

Start date

2023-07-31

Completion date

2023-09-30

Last updated

2023-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Brief summary

The specific aim of this clinical trial is to translate the investigators new 4DE (three sptial dimensions pluse time) stress echocardiographic method to patients with coronary artery disease referred for clinically indicated dobutamine stress/rest echo to evaluate the reproducibility of the technique in this clinical setting.

Interventions

PROCEDUREStress Dobutamine Echocardiographic using 4DE System

Subjects will undergo their clinically indicated stress dobutamine echocardiographic studies using our standard clinical graded dobutamine stress imaging protcol, employing the iE33 4DE system.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

* At least 18 years of age, referred for clinically indicated dobutamine rest/stress TTE * Provide written informed consent to participate in the study * Availability for repease rest/stress TTE within on eweek of clinically indicated study

Exclusion criteria

* Unable to give informed consent * Unstable hemodynamics that would not allow for repease rest/stress dobutamine transthoracic imaging * Recurrent life threatening arrhythmias * Heart rate \>110 BPM * Inadequate windows for transthoracic imagine * Patients that have a narrow-angle glaucoma (contraindication for atropine) * Change in cardiac medications or management including, coronary revascularization beween intial and repeat TTE study.

Design outcomes

Primary

Measure	Time frame	Description
Number of Subjects With an Interpretable 4DE Image	After Stress Echocardiography (Approximately 2 hours)	This outcome will measure feasibility. Data from images will be analyzed with the integrated speckle/shape tracking approach (the method uses boundary detection/shape tracking to quantify left ventricular myocardial deformation)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026