Coronary Artery DiseaseAI INFORMNCT06235112
AI Detection of Incidental Coronary Artery Calcium to Enhance Cardiovascular Disease Prevention
A study testing Electronic health record-based notification of Nanox.AI Coronary Artery Calcification Assessment in people with Coronary Artery Disease, run by Brigham and Women's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Electronic health record-based notification of Nanox.AI Coronary Artery Calcification Assessment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2024to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 40-75 with prior chest CT within last 3 years
Who cannot join
- Prior coronary artery disease
- Prior cancer
- Other life-limiting condition
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02445
Daniel Huck, MD, dhuck@bwh.harvard.edu
Camila Veronica Souza Freire, MD, csouzafreire@bwh.harvard.edu
About this study
Official title: AI Detection of Incidental Coronary Artery Calcium to Enhance Cardiovascular Disease Prevention: A Multicenter Randomized Trial
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
- Coronary Artery Disease
- Being tested
- Electronic health record-based notification of Nanox.AI Coronary Artery Calcification Assessment
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic health record-based notification of Nanox.AI Coronary Artery Calcification AssessmentDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Notification of Coronary Artery Calcification | Experimental | Notification to providers of the presence of coronary artery calcification automatically detected by AI based device (software) on chest CT.
Recommendation of preventive therapy. Receives: Device: Electronic health record-based notification of Nanox.AI Coronary Artery Calcification Assessment |
| Non-notification of Coronary Artery Calcification | No intervention | No notification to providers of the presence of coronary artery calcification on chest CT automatically detected by AI based device (software) on chest CT. No recommendation of preventive therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (4)
Average change in LDL-C after intervention
Average quantitative change in LDL-C (low-density lipoprotein cholesterol) between baseline and 12 months after intervention
Measured: 12 months
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.
Measured: 12 months
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
Measured: 12 months
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start31 Jul 2024
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial of two arms, involving notification to providers (vs non-notification)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Nano-X Imaging Limited
- Responsible party
- Principal investigator, Daniel Michael Huck, MD, MPH, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06235112
- Sponsor's protocol ID
- 2023P002954
- Acronym
- AI INFORM
- Status last verified
- Jan 2026
- First submitted
- 10 Jan 2024
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No IPD will be shared
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AI Detection of Incidental Coronary Artery Calcium to Enhance Cardiovascular Disease Prevention: A Multicenter Randomized Trial
- ClinicalTrials.gov ID
- NCT06235112
- Acronym / sponsor ID
- AI INFORM / 2023P002954
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Nano-X Imaging Limited
- Study start
- 31 Jul 2024 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 31 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial of two arms, involving notification to providers (vs non-notification)
| Arm | Type | Receives |
|---|---|---|
| Notification of Coronary Artery Calcification | Experimental | Device: Electronic health record-based notification of Nanox.AI Coronary Artery Calcification AssessmentNotification to providers of the presence of coronary artery calcification automatically detected by AI based device (software) on chest CT. Recommendation of preventive therapy. |
| Non-notification of Coronary Artery Calcification | No intervention | –No notification to providers of the presence of coronary artery calcification on chest CT automatically detected by AI based device (software) on chest CT. No recommendation of preventive therapy. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged between 40-75 with prior chest CT within last 3 years
Key exclusion criteria (3 listed)
- Prior coronary artery disease
- Prior cancer
- Other life-limiting condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic health record-based notification of Nanox.AI Coronary Artery Calcification AssessmentThe 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). | Device | Notification of Coronary Artery Calcification |
Primary outcome
Proportion of participants with initiation or intensification of lipid-lowering therapy after intervention
Time frame: 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
4 secondary outcomes
Average change in LDL-C after intervention
Time frame: 12 months
Proportion of participants with downstream invasive or noninvasive testing after intervention
Time frame: 12 months
Proportion of participants with major adverse cardiovascular events after intervention
Time frame: 12 months
Proportion of participants with initiation or intensification of other preventive therapies after intervention
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: No. No IPD will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic health record-based notification of Nanox.AI Coronary Artery Calcification Assessment in people with Coronary Artery Disease, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with initiation or intensification of lipid-lowering therapy after intervention (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.