Coronary Artery Disease
Conditions
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.
Interventions
DEVICEElectronic 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).
Sponsors
Brigham and Women's Hospital
Nano-X Imaging Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Randomized controlled trial of two arms, involving notification to providers (vs non-notification)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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 |
Countries
United States
Outcome results
None listed