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

NCT06749132 | Not Yet Recruiting

• 2 other identifiers: 2000038730R01AG089981
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 3

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.

Conditions

Aortic Stenosis

Keywords

aortic stenosis; artificial intelligence

Outcome Measures

Primary Outcomes (1)

• Annualized change in AV Vmax in m/sec/years

  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.

  From baseline TTE to TTE performed at enrollment

Interventions

Transthoracic echocardiogram DIAGNOSTIC_TEST

All study participants will undergo a clinical transthoracic echocardiogram (TTE) performed by certified echocardiography technicians. The TTE includes standard transthoracic examination with acquisition of B-mode, color and spectral Doppler images and videos in line with standard echocardiographic guidelines.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

US adults aged 65 and older with an echocardiogram within the prior 2-3 years that showed aortic sclerosis without stenosis or mild aortic stenosis (AS).

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Yale University: lead
• National Institute on Aging (NIA): collaborator
• Icahn School of Medicine at Mount Sinai: collaborator
• The Methodist Hospital Research Institute: collaborator

Study Sites (3)

Yale New Haven Health System

New Haven, Connecticut, 06519, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

The Methodist Hospital Research Institute

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Rohan Khera, MD, MS

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rohan Khera, MD, MS

CONTACT

203-764-5885; rohan.khera@yale.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: December 27, 2024
• Study Start: April 1, 2026
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE

Locations

US (3)