Deep Learning-enhanced Personalized Monitoring of Aortic Stenosis - The DETECT-AS Prognostic Study

Not yet recruiting

• Conditions: Aortic Stenosis

• Registration Number: NCT06749132
• Lead Sponsor: Yale University

Brief Summary

This study will evaluate the validity of a digital biomarker score for precision risk stratification among older adults with aortic sclerosis or mild aortic stenosis (AS) at three US health systems.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-19
• Study First Submitted QC: 2024-12-19
• Last Update Submitted: 2024-12-19
• Study First Posted: 2024-12-27
• Last Update Posted: 2024-12-27
• Study Start: 2025-09
• Primary Completion: 2028-08
• Study Completion: 2028-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

1. Age 65 years or older
2. Prior transthoracic echocardiogram within the past 2-3 years showing aortic sclerosis without stenosis or mild AS

Exclusion Criteria

1. Opted out of research studies
2. Non-English speaking
3. Any echocardiogram within 24 months of medical record review.
4. Prior history of aortic valve replacement or repair, including transcatheter and surgical AVR with either a bioprosthetic or mechanical valve
5. Presence of implantable cardiac devices, including permanent cardiac pacer, implantable cardioverter-defibrillator, or left ventricular assist device
6. Prior heart transplant
7. History of dementia
8. Unable to attend study visit at echocardiogram lab within four years of most recent echocardiogram.
9. Documented life expectancy of <1 year or current participation in hospice services

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Annualized change in AV Vmax in m/sec/years	From baseline TTE to TTE performed at enrollment	The primary outcome measure is the annualized change in AV Vmax in m/sec/years, defined as the absolute difference between the value on the enrollment and baseline echocardiogram measurement, divided by the time difference between the studies.

Trial Locations

Locations (3)

Santa Clara Medical Center - Kaiser Permanente; 🇺🇸 Santa Clara, California, United States

Yale New Haven Health System; 🇺🇸 New Haven, Connecticut, United States

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States