Study Stopped
Study was never started.
Integrated RF and B-mode Deformation Analysis for 4D Stress Echocardiography
3 other identifiers
interventional
N/A
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jul 2023
Shorter than P25 for not_applicable coronary-artery-disease
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 25, 2014
CompletedFirst Posted
Study publicly available on registry
December 30, 2014
CompletedStudy Start
First participant enrolled
July 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2023
CompletedDecember 13, 2023
December 1, 2023
2 months
November 25, 2014
December 6, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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)
After Stress Echocardiography (Approximately 2 hours)
Study Arms (1)
Stress Dobutamine Echocardiographic 4DE Image System
EXPERIMENTALSubjects will undergo their clinically indicated stress dobutamine echocardiographic studies using our standard clinical graded dobutamine stress imaging protcol, employing the iE33 4DE system.
Interventions
Subjects will undergo their clinically indicated stress dobutamine echocardiographic studies using our standard clinical graded dobutamine stress imaging protcol, employing the iE33 4DE system.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Albert Sinusas, MD
Yale University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 25, 2014
First Posted
December 30, 2014
Study Start
July 1, 2023
Primary Completion
September 1, 2023
Study Completion
September 1, 2023
Last Updated
December 13, 2023
Record last verified: 2023-12