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

NCT ID: NCT02327455

Last Updated: 2023-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-31

Study Completion Date

2023-09-30

Brief Summary

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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

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Stress Dobutamine Echocardiographic 4DE Image 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.

Group Type EXPERIMENTAL

Stress Dobutamine Echocardiographic using 4DE System

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Albert Sinusas, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Other Identifiers

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R01HL0121226

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2R01HL121226-05A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1406014091

Identifier Type: -

Identifier Source: org_study_id