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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02327455
• Other study ID #: 1406014091
• Secondary ID: R01HL01212262R01
• Status: Withdrawn
• Phase: N/A
• Start date: July 2023
• Est. completion date: September 2023

Study information

• Verified date: December 2023
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Heart, Lung, and Blood Institute (NHLBI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)