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

Not Applicable

Withdrawn

• Conditions: Coronary Artery Disease
• Interventions: Procedure: Stress Dobutamine Echocardiographic using 4DE System

• Registration Number: NCT02327455
• Lead Sponsor: Yale University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-11-25
• Study First Submitted QC: 2014-12-22
• Study First Posted: 2014-12-30
• Study Start: 2023-07
• Primary Completion: 2023-09
• Study Completion: 2023-09
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-06
• Last Update Posted: 2023-12-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stress Dobutamine Echocardiographic 4DE Image System	Stress 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.

Primary Outcome Measures

Name	Time	Method
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)