Back to resultsIntegrated RF and B-mode Deformation Analysis for 4D Stress Echocardiography
Primary Purpose
Coronary Artery Disease
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Stress Dobutamine Echocardiographic using 4DE System
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Artery Disease
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Stress Dobutamine Echocardiographic 4DE Image System
Arm Description
Subjects will undergo their clinically indicated stress dobutamine echocardiographic studies using our standard clinical graded dobutamine stress imaging protcol, employing the iE33 4DE system.
Outcomes
Primary Outcome Measures
Number of Subjects With an Interpretable 4DE Image
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT02327455
First Posted
November 25, 2014
Last Updated
January 20, 2023
Sponsor
Yale University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT02327455
Brief Title
Integrated RF and B-mode Deformation Analysis for 4D Stress Echocardiography
Official Title
Integrated RF and B-mode Deformation Analysis for 4D Stress Echocardiography
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2023 (Anticipated)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Stress Dobutamine Echocardiographic 4DE Image System
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
Stress Dobutamine Echocardiographic using 4DE System
Intervention Description
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 Measure Information:
Title
Number of Subjects With an Interpretable 4DE Image
Description
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)
Time Frame
After Stress Echocardiography (Approximately 2 hours)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Donna McMahon
Phone
203-785-5005
Email
donna.mcmahon@yale.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Albert Sinusas, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Integrated RF and B-mode Deformation Analysis for 4D Stress Echocardiography
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