NOTIFY (New Observations Taking Information From Yesterday)

Not Applicable

Not yet recruiting

• Conditions: Atherosclerotic Cardiovascular Disease

• Registration Number: NCT05977413
• Lead Sponsor: Stanford University

Brief Summary

This trial will investigate whether notifying patients and their clinicians of the presence of moderate or severe coronary artery calcium on a low-dose CT scan performed for lung cancer screening results in a lower incidence of death, nonfatal myocardial infarction, or nonfatal stroke as compared with practice guideline reminders.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-19
• Study First Submitted QC: 2023-07-28
• Study First Posted: 2023-08-04
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-25
• Study Start: 2026-03-01
• Primary Completion: 2032-06
• Study Completion: 2032-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40000

Inclusion Criteria

• Age >=18 years
• No known ASCVD
• Lung cancer screenee with low dose CT scan (LDCT) within the last 5 years
• Coronary artery calcium (CAC) score on LDCT >100 Agatston units (AU)
• Not taking a statin or other lipid-lowering therapy (e.g., ezetimibe, bempedoic acid, or PCSK9-lowering therapy)

Exclusion Criteria

• Dementia or other neuropsychiatric disorder that interferes with medication adherence
• CAC scan, coronary CT angiogram, or invasive angiogram since LDCT
• Statin medication intolerance or allergy
• Life expectancy <2 years, e.g., metastatic cancer or active cancer undergoing chemotherapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time to first occurrence of death, nonfatal myocardial infarction, or nonfatal stroke	6 years

Secondary Outcome Measures

Name	Time	Method
Rate of Cardiovascular Death	6 years	Number (%) of participants in each treatment group with cardiovascular death
Rate of Nonfatal Stroke	6 years	Number (%) of participants in each treatment group with nonfatal stroke
Number of revascularization procedures (PCI, CABG, carotid artery revascularization, or peripheral artery revascularization)	6 years	Number of revascularization procedures (PCI, CABG, carotid artery revascularization, or peripheral artery revascularization)
Rate of All-cause Death	6 years	Number (%) of participants in each treatment group with death from any cause.
Initial lipid-lowering therapy prescription rate	within 6 months of 1st notification	Number (%) of participants in each treatment group with active prescriptions of lipid-lowering therapy at 6 months following randomization
Number of Participants with active lipid-lowering therapy prescriptions	At 18 months	Persistence of need for lipid-lowering therapy at 18 months following randomization.
Rate of Nonfatal Myocardial Infarction	6 years	Number (%) of participants in each treatment group with nonfatal myocardial infarction