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

N/ANot Yet RecruitingNCT06749132

Yale University210 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

210

Conditions

Aortic Stenosis

Interventions

Transthoracic echocardiogramDIAGNOSTIC_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

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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

Locations (3)

Yale New Haven Health System

New Haven, Connecticut, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

The Methodist Hospital Research Institute

Houston, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: From baseline TTE to TTE performed at enrollment

Central Contacts

Rohan Khera, MD, MS

CONTACT

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.