NCT06580158 AI in Outpatient Practice for Diagnosing Aortic Stenosis and Diastolic Dysfunction
| NCT ID | NCT06580158 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mayo Clinic |
| Condition | Aortic Stenosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2024-11-08 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,000 participants in total. It began in 2024-11-08 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Two recently developed artificial intelligence-enabled electrocardiogram (AI-ECG) models have been developed to detect aortic stenosis (AS) and diastolic dysfunction (DD). AI-ECG for AS has a sensitivity of 78% and specificity of 74%, and AI-ECG for DD has a sensitivity of 83% and specificity of 80%. However, these models have never been prospectively applied to diagnose AS or DD, which may be useful for patients and providers from a diagnostic and prognostic perspective and especially in settings where access to higher- level medical care is limited. In this study, we aim to determine the clinical utility of these AI-ECG models by prospectively applying them to an outpatient cohort and then completing a focused point-of-care ultrasound to evaluate those who are AI-ECG positive for AS and DD.
Eligibility 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.
Contact & Investigator
Jae Oh, M.D.
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT06580158 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Aortic Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06580158 currently recruiting?
Yes, NCT06580158 is actively recruiting participants. Contact the research team at Rudquist.Brian@mayo.edu for enrollment information.
Where is the NCT06580158 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT06580158 clinical trial?
NCT06580158 is sponsored by Mayo Clinic. The principal investigator is Jae Oh, M.D. at Mayo Clinic. The trial plans to enroll 2,000 participants.