NCT06235112

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for not_applicable coronary-artery-disease

Timeline
18mo left

Started Jul 2024

Typical duration for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress56%
Jul 2024Dec 2027

First Submitted

Initial submission to the registry

January 10, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 31, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

July 31, 2024

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

2.8 years

First QC Date

January 10, 2024

Last Update Submit

January 21, 2026

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Average change in LDL-C after intervention

    12 months

  • Proportion of participants with downstream invasive or noninvasive testing after intervention

    12 months

  • Proportion of participants with major adverse cardiovascular events after intervention

    12 months

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

    6 months

Study Arms (2)

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.

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.

Interventions

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).

Notification of Coronary Artery Calcification

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged between 40-75 with prior chest CT within last 3 years

You may not qualify if:

  • Prior coronary artery disease
  • Prior cancer
  • Other life-limiting condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02445, United States

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized controlled trial of two arms, involving notification to providers (vs non-notification)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 10, 2024

First Posted

January 31, 2024

Study Start

July 31, 2024

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

January 23, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

No IPD will be shared

Locations

US(1)