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NCT06580158 · ClinicalTrials.gov registry record
AI in Outpatient Practice for Diagnosing Aortic Stenosis and Diastolic Dysfunction
A clinical trial of Aortic Stenosis and Diastolic Dysfunction, sponsored by Mayo Clinic.
- Recruiting
- Registry status
- 2,000
- Enrollment target
- 1
- Study location
NCT06580158: Recruiting study of Aortic Stenosis and Diastolic Dysfunction, sponsored by Mayo Clinic.
NCT06580158 is a study of Aortic Stenosis and Diastolic Dysfunction that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 2,000 participants, above the 1,285-participant average among 26 other Aortic Stenosis trials with a reported enrollment target (56% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06580158, a study of Aortic Stenosis and Diastolic Dysfunction, is actively recruiting participants, sponsored by Mayo Clinic.
- RECRUITING
- Registry status
- 2,000 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Positive AI-ECG will be determined by the sensitivity, specificity, positive predictive value, and negative predictive value.
Conditions Studied
Interventions
- DEVICE AI-ECG Dashboard
- DIAGNOSTIC_TEST Point of care ultrasound (POCUS)
Study Locations (1)
Minnesota
- Mayo Clinic - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,000 participants |
| Start Date | 2024-11-08 |
| Est. Completion | 2027-03 |
What NCT06580158 shows while recruiting
NCT06580158 is an observational study that tracks outcomes without assigning an intervention. Its 2,000 participants enrollment target places it among the larger protocols in the corpus, above the 1,285-participant average among 26 other Aortic Stenosis trials with a reported enrollment target (56% higher).
The record links to 2 conditions, with Aortic Stenosis appearing as the primary indexed condition, and to 2 interventions - of which AI-ECG Dashboard is the first listed.
NCT06580158 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT06580158 about?
NCT06580158 is a clinical study titled "AI in Outpatient Practice for Diagnosing Aortic Stenosis and Diastolic Dysfunction". 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%...
What is the current status of trial NCT06580158?
This trial is currently recruiting. The enrollment target is 2,000 participants. The study started on 2024-11-08. Estimated completion is 2027-03.
What conditions does trial NCT06580158 study?
This clinical trial studies the following conditions: Aortic Stenosis, Diastolic Dysfunction.
What interventions are being tested in trial NCT06580158?
The interventions under investigation include: AI-ECG Dashboard (DEVICE), Point of care ultrasound (POCUS) (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT06580158?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06580158 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Aortic Stenosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06580158's enrollment target sits among peer trials
2,000 4th of 26 higher than 23 of 26 other Aortic Stenosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Aortic Stenosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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