Using Point-of-Care Echocardiography to Assess Aortic Stenosis
Point-of-Care Echocardiography in Patients with Known or Suspected Aortic Stenosis
NA · Caption Health, Inc. · NCT06717373
This study is testing a new way to use ultrasound images to see if an AI tool can better assess aortic stenosis in patients who need heart checks.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Caption Health, Inc. (industry) |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06717373 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to capture echocardiographic images from patients who are indicated for an echocardiographic examination, specifically focusing on those with known or suspected aortic stenosis. Participants will undergo standard echocardiographic examinations alongside additional scans using a Point of Care Ultrasound device. The collected images will be utilized to test and potentially validate an AI-based algorithm designed to assess aortic valve stenosis. The study will involve a total of up to 200 patients, with the first 45 serving to fine-tune the algorithm before the remaining participants are used for clinical validation.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are scheduled for an echocardiographic examination and have known or suspected valve disease.
Not a fit: Patients with artificial aortic valves or those 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 diagnosing aortic stenosis using AI technology.
How similar studies have performed: Other studies utilizing AI in echocardiography have shown promising results, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients scheduled for an echocardiographic examination * Patients ≥18 years old * Patient with known or suspected valve disease based on medical history Exclusion Criteria: * Patients with artificial aortic valves * Unable to lie flat for study * Patients experiencing a known or suspected acute cardiac event * Patients unwilling or unable to give written informed consent
Where this trial is running
Chicago, Illinois
- Northwestern University — Chicago, Illinois, United States (RECRUITING)
Study contacts
- Principal investigator: Akhil Narang, MD — Northwestern University
- Study coordinator: Yngvil K Thomas, MSc
- Email: yngvil.thomas@gehealthcare.com
- Phone: +1 312-316-5632
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.
Conditions: Patients with an Indication for an Echocardiographic Examination with Suspicion of Valcular Heart Disease