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

Coronary Artery Disease Clinical Trial

— AI INFORM  

Official title:

AI Detection of Incidental Coronary Artery Calcium to Enhance Cardiovascular Disease Prevention: A Multicenter Randomized Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06235112
• Other study ID #: 2023P002954
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: July 1, 2026

Study information

• Verified date: January 2024
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1500
• Est. completion date: July 1, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Coronary Artery Disease

Intervention

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).

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Nano-X Imaging Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants with initiation or intensification of lipid-lowering therapy after intervention	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	6 months
Secondary	Average change in LDL-C after intervention	Average quantitative change in LDL-C (low-density lipoprotein cholesterol) between baseline and 12 months after intervention	12 months
Secondary	Proportion of participants with downstream invasive or noninvasive testing after intervention	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.	12 months
Secondary	Proportion of participants with major adverse cardiovascular events after intervention	Composite outcome: Occurrence of an adverse cardiovascular event (yes/no) including cardiovascular death, myocardial infarction, or stroke by 12 months after the intervention	12 months
Secondary	Proportion of participants with initiation or intensification of other preventive therapies after intervention	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	6 months