Automated tool for guiding cardiac ultrasound imaging
Optimization of an Ultrasound Cardiac Guidance Tool
This study tests a new tool that helps doctors take better heart ultrasound images to see if it improves the quality of the exams for heart patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Sponsor | UltraSight Industry-sponsored |
| Locations | 1 site (Detroit, Michigan) |
| Trial ID | NCT05649826 on ClinicalTrials.gov |
What this trial studies
This observational study examines echocardiography images from cardiac patients using a newly developed automated guidance tool. Participants will undergo a transthoracic echocardiography exam performed by a trained sonographer to capture the necessary images. The study aims to evaluate the effectiveness of the guidance tool in improving the quality of ultrasound imaging in this patient population.
Who should consider this trial
Good fit: Ideal candidates include males and females aged 18 years and older who can provide informed consent.
Not a fit: Patients who are pregnant, have severe obesity, or are experiencing acute cardiac events may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy and efficiency of cardiac ultrasound imaging, leading to better patient outcomes.
How similar studies have performed: While this approach is innovative, similar studies have not been widely reported, indicating that this may be a novel exploration in the field.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Males and females, aged 18 years and older 2. Subject willing and able to give written informed consent Exclusion Criteria: 1. Emergency (non-elective) admission within 24 h prior to participating in the study 2. Female subjects who are pregnant (women of childbearing potential will provide a statement that they are not pregnant incorporated in the ICF 3. Unable to lie as required in all the classic positions for standard TTE exam: supine on back / left decubitus 4. Subjects who currently participate in a clinical trial, involving interventional cardiac devices. 5. Subjects who have prior Echo exam with description of Low/Poor quality exam in the echo report. 6. Subjects with BMI above 40. 7. Subjects experiencing a known or suspected acute cardiac event. 8. Subjects with severe chest wall deformity as per previous medical records and physical examination. 9. Subjects who have undergone pneumonectomy. 10. Subjects whose anatomy does not lend itself to yield diagnosable standard echocardiography clips (i.e., situs inversus with dextrocardia, single ventricle anatomy due to congenital heart disease, etc.).
Where this trial is running
Detroit, Michigan
- Wayne University — Detroit, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Robert Ehrman, MD — Wayne University Emergency medicine
- Study coordinator: Robert Ehrman, MD
- Email: rehrman@med.wayne.edu
- Phone: 313-5771268
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.