Using AI to Diagnose Heart Conditions in Outpatients
The Clinical Utility of Artificial Intelligence-enabled Electrocardiograms in the Outpatient Practice - Diagnosing Aortic Stenosis and Diastolic Dysfunction
This study is testing if new AI tools can help doctors diagnose heart problems like aortic stenosis and diastolic dysfunction in older patients during their regular check-ups.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06580158 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of two artificial intelligence-enabled electrocardiogram (AI-ECG) models designed to detect aortic stenosis and diastolic dysfunction in an outpatient setting. The AI-ECG models have shown promising sensitivity and specificity but have not been prospectively tested in clinical practice. Participants aged 60 and older who are scheduled for a clinical ECG will be assessed using these AI models, followed by a focused point-of-care ultrasound for those who test positive. The goal is to determine the clinical utility of these AI tools in diagnosing heart conditions, particularly in areas with limited access to advanced medical care.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 60 and older who are scheduled for a clinical ECG.
Not a fit: Patients younger than 59 years or those not scheduled for a clinical ECG will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance early diagnosis and management of aortic stenosis and diastolic dysfunction, improving patient outcomes.
How similar studies have performed: While AI applications in diagnostics are emerging, this specific approach has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ≥ 60 years of age must have a clinical scheduled ECG performed. Exclusion Criteria: * \< 59 years of age * Is not scheduled for a clinical ECG * Unable to provide consent.
Where this trial is running
Rochester, Minnesota
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Jae Oh, M.D. — Mayo Clinic
- Study coordinator: Brian Rudquist
- Email: Rudquist.Brian@mayo.edu
- Phone: (507) 538-5146
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.