Deep Learning Enhanced Detection of Aortic Stenosis - The DETECT-AS-Diagnostic Study

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT06749145
Status
Enrolling By Invitation

Conditions

  • Aortic Stenosis

Eligibility Criteria

Sex
ALL
Age
70 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Portable 1-lead electrocardiogram — DIAGNOSTIC_TEST
    Portable 1-lead electrocardiogram (ECG) performed with the FDA-approved AliveCor KardiaMobile device.
  • Point-of-care ultrasound — DIAGNOSTIC_TEST
    Point-of-care ultrasound performed with the FDA-approved VScan Air device.
  • AI-ECG risk algorithm — OTHER
    Artificial intelligence (AI) risk algorithm for aortic stenosis using a 1-lead electrocardiogram
  • AI-POCUS — OTHER
    Artificial intelligence (AI) risk algorithm for aortic stenosis using cardiac ultrasound plax videos.

Study Details

The DETECT-AS Diagnostic Study will assess the performance of artificial intelligence (AI) risk predictions to detect aortic stenosis using results from portable electrocardiogram (ECG) and cardiac ultrasound devices.

Key Dates

Start date
Sep 16, 2025
Status verified
Nov 2025
Primary completion
Aug 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
410 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Intervention
    The intervention arm will undergo sequential screening for aortic stenosis using portable 1-lead electrocardiograms (ECGs), followed by point-of-care ultrasound (POCUS), if indicated, by artificial intelligence (AI)-based risk algorithms.
  • Sham Comparator: Control
    The control arm will undergo a portable 1-lead electrocardiogram (ECG), with 10% randomly assigned to undergo point-of-care ultrasound (POCUS).

Primary Outcome Measure

Number of participants diagnosed with advanced aortic stenosis (AS) by transthoracic echocardiogram (TTE) [ Time Frame: Until 12 months from the baseline visit ]

Locations (3)

FacilityCityStateZIPSite coordinators
Yale New Haven Health SystemNew HavenConnecticut06519-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
The Methodist Hospital Research InstituteHoustonTexas77030-

Find similar trials in New Haven, CT

By research site
Yale New Haven Health System· New Haven, CTIcahn School of Medicine at Mount Sinai· New York, NYThe Methodist Hospital Research Institute· Houston, TX

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