Using AI to Measure Heart Pressure Non-Invasively
Valutazione Delle Pressioni di Riempimento Del Ventricolo Sinistro Attraverso l'Impiego di un Software di Intelligenza Artificiale Applicato Alla Stima Dello Strain Atriale Sinistro Con Ecocardiografia Speckletracking: Studio di Validazione Mediante Cateterismo Cardiaco
This study is testing a new AI tool that uses ultrasound images of the heart to see if it can accurately measure heart pressure without needing invasive procedures.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Istituto Auxologico Italiano Academic / other |
| Locations | 1 site (Andover, Massachusetts) |
| Trial ID | NCT05768698 on ClinicalTrials.gov |
What this trial studies
This observational study aims to validate an artificial intelligence software that estimates left ventricular filling pressure (LVFP) non-invasively through echocardiography. The study will compare the AI-generated estimates with those obtained from invasive methods like left and right heart catheterization. Additionally, it will assess the software's effectiveness in detecting elevated left ventricular end-diastolic pressure (LVEDP) compared to existing algorithms. The study will involve patients who can provide high-quality echocardiographic images of the left atrium.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who can provide informed consent and have good echocardiographic imaging quality.
Not a fit: Patients with significant mitral valve disease, arrhythmias, or those taking certain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a safer, non-invasive method for assessing heart pressure in patients with heart failure.
How similar studies have performed: Other studies have shown promise in using AI for echocardiographic assessments, but this specific application is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ≥ 18 yo, * Signed informed consent to be part of this study, * No pregnancy, * Good acoustic window and patient cooperation to obtain good 2- and 3-dimensional datasets focused on left atrium (LA), Exclusion Criteria: * Unwillingness to be part of the study, * Patients with poor 2-dimensional imaging quality in ≥ 1 LA segment or lacking of a discernible R-R interval, which might preclude accurate strain measurements, * Patients with more than mild mitral valve heart disease, aortic regurgitation, left side valvular prosthesis or mitral valve repair, mitral annulus calcification (≥ 5 mm), * Patients with history or presence of atrial fibrillation (AF), supraventricular arrhythmias, ventricular paced rhythm, left bundle branch block (LBBB), * Patients taking diuretics or vasodilators (nitrates) on the day of the examination, which could alter loading conditions.
Where this trial is running
Andover, Massachusetts
- Philips Healthcare — Andover, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Luigi Badano, MD, Ph.D.
- Email: l.badano@auxologico.it
- Phone: +390261911
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.