Artificial Intelligence for Early Detection of Peripheral Artery Disease

Sponsor
University of California, San Diego
Study ID
NCT06505317
Status
Not Yet Recruiting

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Conditions

  • Peripheral Arterial Disease

Eligibility Criteria

Sex
ALL
Age
50 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

  • AI-based PAD screening intervention — DIAGNOSTIC_TEST
    Providers will receive alerts for a patient that is flagged by model as being "high risk" for PAD. This will allow the provider to review the alert, check the patient's previous history, develop additional questions to assess the risk of PAD, and initiate orders prior to seeing a patient. Depending on their assessment during the patient visit the provider may choose to order an ABI test (or perform one at bedside) and/or initiate other secondary prevention measures. All patients for which an alert is triggered will be included for secondary analysis.

Study Details

The goal of this clinical trial is to test an AI-based screening tool that will help to identify patients at high risk of having undiagnosed peripheral artery disease. The primary outcome measure is overall rate of new PAD diagnoses. Secondary outcomes include rate of new secondary prevention measures initiated for PAD, which will include new prescriptions for antiplatelets, PAD-dosed rivaroxaban, statins, smoking cessation counseling or referrals, and/or supervised exercise therapy referrals also aggregated at a clinic and site level.

Key Dates

First listed
Jul 17, 2024
Start date
Jul 1, 2026
Status verified
Jul 2024
Primary completion
Jul 1, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
7,800 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Clinical Site 1
    Randomized to start AI-based PAD screening interventionat week 13.
  • Experimental: Clinical Site 2
    Randomized to start AI-based PAD screening intervention at Week 26.
  • Experimental: Clinical Site 3
    Randomized to start AI-based PAD screening intervention at Week 39.

Primary Outcome Measure

PAD Diagnosis Rate [ Time Frame: During 13-39 weeks prior to intervention compared to 13-39 weeks during intervention depending on timing of randomization to intervention period. ]

Central Contacts

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