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Notification of Coronary Artery Calcification for Coronary Artery Disease (AI INFORM Trial)

N/A

Waitlist Available

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

AI INFORM Trial 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.Check my eligibility

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.See study design

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.

AI INFORM Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

AI INFORM 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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor

1,612 Previous Clinical Trials

11,469,075 Total Patients Enrolled

23 Trials studying Coronary Artery Disease

23,522 Patients Enrolled for Coronary Artery Disease

Nano-X Imaging LimitedUNKNOWN

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I meet the necessary criteria to participate in this research investigation?

"To be eligible for this medical research, individuals must have a diagnosis of coronary artery disease and fall between the age range of 40 to 75 years old. The study aims to enroll approximately 1500 participants."

Answered by AI

Are individuals still able to enroll in this research study at the moment?

"According to the information provided on clinicaltrials.gov, this specific clinical trial is not currently seeking participants. The study was initially posted on March 1st, 2024 and its last update was made on January 23rd, 2024. However, it's worth noting that there are currently 940 other ongoing clinical trials actively recruiting patients at present."

Answered by AI

Are individuals who are above the age of 80 eligible to participate in this study?

"To be eligible for this clinical trial, applicants must be between the ages of 40 and 75. It is worth noting that there are currently 47 ongoing trials specifically intended for individuals under the age of 18, as well as 887 trials available to patients over the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Daniel Michael Huck, MD, MPH 2024. "AI Detection of Incidental Coronary Artery Calcium to Enhance Cardiovascular Disease Prevention". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06235112.

All > Coronary Artery Disease