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OpenTrials
Enrolling by Invitation

NCT Number: NCT06749132

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

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.

Enrolling by Invitation

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Yale New Haven Health System, New Haven, Connecticut, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Annualized change in AV Vmax in m/sec/years

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Icahn School of Medicine at Mount Sinai
  • National Institute on Aging (NIA)
  • The Methodist Hospital Research Institute

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Dec 27, 2024
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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