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

Not Applicable

Recruiting

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

• Registration Number: NCT06235112
• Lead Sponsor: Brigham and Women's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-10
• Study First Submitted QC: 2024-01-23
• Study First Posted: 2024-01-31
• Study Start: 2024-07-31
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-05
• Last Update Posted: 2024-08-06
• Primary Completion: 2026-01-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1500

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Notification of Coronary Artery Calcification	Electronic health record-based notification of Nanox.AI Coronary Artery Calcification Assessment	Notification to providers of the presence of coronary artery calcification automatically detected by AI based device (software) on chest CT. Recommendation of preventive therapy.

Primary Outcome Measures

Name	Time	Method
Proportion of participants with initiation or intensification of lipid-lowering therapy after intervention	6 months	Initiation or intensification of therapy (yes/no) by 6 months after the intervention. Initiation: starting lipid-lowering therapy; intensification: increasing the dose of lipid-lowering therapy

Secondary Outcome Measures

Name	Time	Method
Proportion of participants with major adverse cardiovascular events after intervention	12 months	Composite outcome: Occurrence of an adverse cardiovascular event (yes/no) including cardiovascular death, myocardial infarction, or stroke by 12 months after the intervention
Average change in LDL-C after intervention	12 months	Average quantitative change in LDL-C (low-density lipoprotein cholesterol) between baseline and 12 months after intervention
Proportion of participants with downstream invasive or noninvasive testing after intervention	12 months	Composite outcome: Downstream testing (yes/no) including coronary artery calcium score, coronary CT angiography, invasive coronary angiography, or stress testing by 12 months after the intervention.
Proportion of participants with initiation or intensification of other preventive therapies after intervention	6 months	Initiation or intensification of preventive therapy (yes/no) by 6 months after the intervention. Preventive therapy includes any of the following: aspirin, antihypertensive therapy, metabolic therapy. Initiation: starting preventive therapy; intensification: increasing the dose of preventive therapy

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States