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AI Detection for Cardiovascular Disease Prevention (AI INFORM Trial)

N/A

Recruiting

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Other life-limiting condition

Prior coronary artery disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial, called AI INFORM, is a research study that aims to determine if giving doctors information about the presence and severity of calcium build-up in the arteries can lead to better prevention of heart disease

Who is the study for?

This trial is for individuals aged 40-75 who've had a chest CT scan in the last 3 years and have no history of coronary artery disease, cancer, or any other life-limiting conditions. It's aimed at enhancing cardiovascular disease prevention.

What is being tested?

The AI INFORM study is testing if notifying clinicians about the presence and amount of calcium buildup in arteries using an AI tool (Nanox.AI) leads to better preventive care. This involves analyzing past chest CT scans without contrast.

What are the potential side effects?

Since this trial involves analysis of existing medical records rather than direct patient interventions, there are no direct side effects from participating in this study.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any other condition that could shorten my life.

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I have had heart disease related to my arteries.

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I have had cancer before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of participants with initiation or intensification of lipid-lowering therapy after intervention

Secondary study objectives

Average change in LDL-C after intervention

Proportion of participants with downstream invasive or noninvasive testing after intervention

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

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Notification of Coronary Artery CalcificationExperimental Treatment1 Intervention

Notification to providers of the presence of coronary artery calcification automatically detected by AI based device (software) on chest CT. Recommendation of preventive therapy.

Group II: Non-notification of Coronary Artery CalcificationActive Control1 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.

0 / 3Eligibility criteria met