Automated Ultrasound Cardiac Guidance Tool
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Ultrasound Imaging. Basic parameters: 18 years — 120 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Optimization of an Ultrasound Cardiac Guidance Tool
Overview
This research examines echocardiography images taken from cardiac patients in relation to the guidance tool developed
Detailed description
The study is an open label, single arm prospective study. This goal of the study is to learn about echocardiography images in relation to the developed guidance tool software in cardiac patients population. Participants will undergo one session of transthoracic echocardiography exam. The ultrasound will be performed by a sonographer for images acquiring purposes
Primary outcome measures
- Acquisition of transthoracic echocardiography media from up to 200 subjects [Time frame: up to 5 year]
Eligibility criteria
Inclusion criteria
- Males and females, aged 18 years and older
- Subject willing and able to give written informed consent
Exclusion criteria
- Emergency (non-elective) admission within 24 h prior to participating in the study
- Female subjects who are pregnant (women of childbearing potential will provide a statement that they are not pregnant incorporated in the ICF
- Unable to lie as required in all the classic positions for standard TTE exam: supine on back / left decubitus
- Subjects who currently participate in a clinical trial, involving interventional cardiac devices.
- Subjects who have prior Echo exam with description of Low/Poor quality exam in the echo report.
- Subjects with BMI above 40.
- Subjects experiencing a known or suspected acute cardiac event.
- Subjects with severe chest wall deformity as per previous medical records and physical examination.
- Subjects who have undergone pneumonectomy.
- 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.).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
United States · 1 center
- Wayne University — Detroit
Identifiers
NCT: NCT05649826 · 002-30 US