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NCT Number: NCT06235112

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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02445, United States

Location status: Recruiting

Location contact

Camila Veronica Souza Freire, MD

CONTACT

[email protected]

Daniel Huck, MD

CONTACT

[email protected]

Daniel Huck, MD

PRINCIPAL_INVESTIGATOR

Ron Blankstein, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electronic health record-based notification of Nanox.AI Coronary Artery Calcification Assessment

Device

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).

Primary outcomes

  1. 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

Secondary outcomes

  1. Average change in LDL-C after intervention

    Time frame: 12 months

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

  2. Proportion of participants with downstream invasive or noninvasive testing after intervention

    Time frame: 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.

  3. Proportion of participants with major adverse cardiovascular events after intervention

    Time frame: 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

  4. Proportion of participants with initiation or intensification of other preventive therapies after intervention

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Nano-X Imaging Limited

Registry information

Official study title

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

Acronym: AI INFORM

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jan 31, 2024
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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