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

Mass General Brigham

Status: Enrolling

Conditions: Coronary Artery Disease

Treatments: Device: Electronic health record-based notification of Nanox.AI Coronary Artery Calcification Assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT06235112

2023P002954

Details and patient eligibility

About

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.

Enrollment: 1,500 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged between 40-75 with prior chest CT within last 3 years

Exclusion criteria

• Prior coronary artery disease
• Prior cancer
• Other life-limiting condition

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,500 participants in 2 patient groups

Notification of Coronary Artery Calcification

Experimental group

Description:

Notification to providers of the presence of coronary artery calcification automatically detected by AI based device (software) on chest CT. Recommendation of preventive therapy.

Treatment:

Device: Electronic health record-based notification of Nanox.AI Coronary Artery Calcification Assessment

Non-notification of Coronary Artery Calcification

No Intervention group

Description:

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.