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

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Mass General Brigham

Status

Not yet 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

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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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