NOTIFY (New Observations Taking Information From Yesterday) (NOTIFY)

NOTIFY-OUTCOMES (New Observations Taking Information From Yesterday)

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.

Study Overview

• Status: Withdrawn
• Conditions: Atherosclerotic Cardiovascular Disease
• Intervention / Treatment: Other: CAC Notification; Other: Clinician Guideline Reminder

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient-Clinician CAC Notification; The CAC Notification intervention sent to both patients and clinicians has five features. 1) Results of a high CAC score (>100 AU) detected on the patient's prior chest CT, 2) an image of the patient's CAC clearly marked, 3) a recommendation to have a patient-clinician risk discussion, 4) specific statin dosing recommended by guidelines, and 5) a link to the prevention gidelines.	Other: CAC Notification; Patient-Clinician CAC Notification. The CAC Notification intervention sent to both patients and clinicians has five features. 1) Results of a high CAC score (>100 AU) detected on the patient's prior chest CT, 2) an image of the patient's CAC clearly marked, 3) a recommendation to have a patient-clinician risk discussion, 4) specific statin dosing recommended by guidelines, and 5) a link to the prevention gidelines.
Other: Clinician Guideline Reminder; The Guideline Reminder intervention sent to primary care clinicians has five features. 1) A reminder that all patients should have their 10-year risk for ASCVD events calculated, 2) a figure of the recommended treatment algorithm according to ASCVD 10-year risk, 3) a nudge that patients who qualify for lung cancer screening are generally at high ASCVD risk, 4) a reminder that patients at elevated risk should be engaged in shared decision-making to discuss statin therapy and other preventive interventions, and 5) access to the complete ACC/AHA Primary Prevention Guidelines and the online 10-year ASCVD risk estimator.	Other: Clinician Guideline Reminder; The Guideline Reminder intervention sent to primary care clinicians has five features. 1) A reminder that all patients should have their 10-year risk for ASCVD events calculated, 2) a figure of the recommended treatment algorithm according to ASCVD 10-year risk, 3) a nudge that patients who qualify for lung cancer screening are generally at high ASCVD risk, 4) a reminder that patients at elevated risk should be engaged in shared decision-making to discuss statin therapy and other preventive interventions, and 5) access to the complete ACC/AHA Primary Prevention Guidelines and the online 10-year ASCVD risk estimator.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to first occurrence of death, nonfatal myocardial infarction, or nonfatal stroke	6 years

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Specific Statin Prescribed and Statin Dose	Rate of prescription of specific statins at specific doses	1 year post randomization
Rate of Prescription of Non-statin Lipid-lowering Medications	Rate of prescription of specific non-statins	1 year post randomization
Rate of Aspirin Prescription	Rate of aspirin prescription by treatment group	1 year post randomization
Number of Antihypertensive Medications	Number of antihypertensive medications prescribed per participant by treatment group	1 year post randomization
Median LDL-C Concentration	Median LDL cholesterol concentration by treatment group	1 year post randomization
Percentage of participants with LDL-C <70 mg/dL	Percentage of participants with LDL-C <70 mg/dL by treatment group	1 year post randomization
Systolic blood pressure	Median systolic blood pressure value in mmHg by treatment group	1 year post randomization
Percentage of participants with Systolic Blood Pressure <130 mmHg	Percentage of participants with systolic blood pressure <130 mmHg by treatment group	1 year post randomization
Body Mass Index	Median body mass index value by treatment group	1 year post randomization
Total number of primary care clinical encounters during the trial		6 years
Number of cardiology encounters		6 years
Number of cardiovascular diagnostic noninvasive tests		6 years

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: Patient-Centered Outcomes Research Institute; Duke University
• Investigators: Principal Investigator: David J Maron, MD, Stanford University

Publications and helpful links

General Publications

• Sandhu AT, Rodriguez F, Ngo S, Patel BN, Mastrodicasa D, Eng D, Khandwala N, Balla S, Sousa D, Maron DJ. Incidental Coronary Artery Calcium: Opportunistic Screening of Previous Nongated Chest Computed Tomography Scans to Improve Statin Rates (NOTIFY-1 Project). Circulation. 2023 Feb 28;147(9):703-714. doi: 10.1161/CIRCULATIONAHA.122.062746. Epub 2022 Nov 7.
• Eng D, Chute C, Khandwala N, Rajpurkar P, Long J, Shleifer S, Khalaf MH, Sandhu AT, Rodriguez F, Maron DJ, Seyyedi S, Marin D, Golub I, Budoff M, Kitamura F, Takahashi MS, Filice RW, Shah R, Mongan J, Kallianos K, Langlotz CP, Lungren MP, Ng AY, Patel BN. Automated coronary calcium scoring using deep learning with multicenter external validation. NPJ Digit Med. 2021 Jun 1;4(1):88. doi: 10.1038/s41746-021-00460-1.

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): June 1, 2032
• Study Completion (Estimated): June 1, 2032

Study Registration Dates

• First Submitted: July 19, 2023
• First Submitted That Met QC Criteria: July 28, 2023
• First Posted (Actual): August 4, 2023

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 7, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis
• Other Study ID Numbers: 71202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No