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

Not Applicable
Recruiting
Conditions
Coronary Artery Disease
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

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
Primary Outcome Measures
NameTimeMethod
Proportion of participants with initiation or intensification of lipid-lowering therapy after intervention6 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
NameTimeMethod
Proportion of participants with major adverse cardiovascular events after intervention12 months

Composite outcome: Occurrence of an adverse cardiovascular event (yes/no) including cardiovascular death, myocardial infarction, or stroke by 12 months after the intervention

Proportion of participants with downstream invasive or noninvasive testing after intervention12 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 intervention6 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

Average change in LDL-C after intervention12 months

Average quantitative change in LDL-C (low-density lipoprotein cholesterol) between baseline and 12 months after intervention

Trial Locations

Locations (1)

Brigham and Women's Hospital

🇺🇸

Boston, Massachusetts, United States

Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Daniel Huck, MD
Principal Investigator
Camila Veronica Souza Freire, MD
Contact
csouzafreire@bwh.harvard.edu
Ron Blankstein, MD
Principal Investigator

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