Recruiting

AI Detection

Sponsor:

Brigham and Women's Hospital

Code:

NCT06235112

Conditions

Coronary Artery Disease

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

Brief summary:

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.

Conditions

Coronary Artery Disease

Study ID

NCT06235112

Start date

Jul 31, 2024

Status verified date

Jan, 2026

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

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

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).

Primary outcome measure

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

Central Contacts and Locations

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02445

Contacts

Daniel Huck, MD

dhuck@bwh.harvard.edu

Camila Veronica Souza Freire, MD

csouzafreire@bwh.harvard.edu

Principal Investigator:

Daniel Huck, MD

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Jan 23, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2026-01-23.