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

December 6, 2023 updated by: Yale University
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects With an Interpretable 4DE Image
Time Frame: 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)
After Stress Echocardiography (Approximately 2 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Albert Sinusas, MD, Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2023

Primary Completion (Estimated)

September 1, 2023

Study Completion (Estimated)

September 1, 2023

Study Registration Dates

First Submitted

November 25, 2014

First Submitted That Met QC Criteria

December 22, 2014

First Posted (Estimated)

December 30, 2014

Study Record Updates

Last Update Posted (Estimated)

December 13, 2023

Last Update Submitted That Met QC Criteria

December 6, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1406014091
  • R01HL0121226 (Other Grant/Funding Number: NHLBI)
  • 2R01HL121226-05A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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