AI Detection of Incidental Coronary Artery Calcium to Enhance Cardiovascular Disease Prevention

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT06235112
Status
Recruiting
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Conditions

  • Coronary Artery Disease

Eligibility Criteria

Sex
ALL
Age
40 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Electronic health record-based notification of Nanox.AI Coronary Artery Calcification Assessment — DEVICE
    The intervention involves electronic health record, email, or letter notification about the presence of coronary artery calcification on chest CT and recommendation of preventive therapy. This is based on results of the automatic detection of coronary artery calcification from AI device (software).

Study Details

AI INFORM is a multicenter randomized trial that will test the hypothesis that providing clinicians information on the presence and amount of coronary artery calcifications (CAC), will result in initiation or intensification of preventive therapies. The study will use a cloud-based artificial intelligence (AI) platform (Nanox.AI) that can analyze non contrast chest CT and estimate the amount of CAC.

Key Dates

Start date
Jul 31, 2024
Status verified
Jan 2026
Primary completion
Jun 1, 2027
Completion
Dec 1, 2027

Study Design

Enrollment
1,500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Notification of Coronary Artery Calcification
    Notification to providers of the presence of coronary artery calcification automatically detected by AI based device (software) on chest CT. Recommendation of preventive therapy.
  • No Intervention: Non-notification of Coronary Artery Calcification
    No notification to providers of the presence of coronary artery calcification on chest CT automatically detected by AI based device (software) on chest CT. No recommendation of preventive therapy.

Primary Outcome Measure

Proportion of participants with initiation or intensification of lipid-lowering therapy after intervention [ Time Frame: 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02445
Daniel Huck, MD
[email protected]
Camila Veronica Souza Freire, MD
[email protected]
Daniel Huck, MD (PRINCIPAL_INVESTIGATOR)
Ron Blankstein, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Brigham and Women's Hospital· Boston, MA

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