Trials / Recruiting
RecruitingNCT06235112
AI Detection of Incidental Coronary Artery Calcium to Enhance Cardiovascular Disease Prevention
AI Detection of Incidental Coronary Artery Calcium to Enhance Cardiovascular Disease Prevention: A Multicenter Randomized Trial
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1,500 (estimated)
- Sponsor
- Brigham and Women's Hospital · Academic / Other
- Sex
- All
- Age
- 40 Years – 75 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | 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). |
Timeline
- Start date
- 2024-07-31
- Primary completion
- 2027-06-01
- Completion
- 2027-12-01
- First posted
- 2024-01-31
- Last updated
- 2026-01-23
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06235112. Inclusion in this directory is not an endorsement.