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Enrolling by invitation NCT06749145

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

No phase Interventional Aortic Stenosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Portable 1-lead electrocardiogram, Point-of-care ultrasound, AI-ECG risk algorithm, AI-POCUS.
Who it may be relevant to
Registry conditions: Aortic Stenosis. Basic parameters: from 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

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

Eligibility criteria

Inclusion criteria

  • Age 70 years or older
  • Attending a routine outpatient primary care clinic at one of the three enrollment sites

Exclusion criteria

  • Opted out of research studies
  • Non-English speaking
  • Urgent or emergent visits, defined as a visit for an illness or injury that needs attention quickly or is life-threatening
  • Any echocardiogram within 12 months of clinic visit
  • Prior history of moderate or severe AS
  • 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
  • Documented life expectancy of <1 year or current participation in hospice services.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Diagnostic

Study locations

United States · 3 centers
  • Yale New Haven Health System — New Haven
  • Icahn School of Medicine at Mount Sinai — New York
  • The Methodist Hospital Research Institute — Houston

Identifiers

NCT: NCT06749145 · 2000038634 · R01AG089981

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗