Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06580158
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-29
Brief Title:
AI in Outpatient Practice for Diagnosing Aortic Stenosis and Diastolic Dysfunction
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Clinical Utility of Artificial Intelligence-enabled Electrocardiograms in the Outpatient Practice - Diagnosing Aortic Stenosis and Diastolic Dysfunction
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None