NOTIFY (New Observations Taking Information From Yesterday)

Atherosclerotic Cardiovascular Disease Clinical Trial

— NOTIFY  

Official title:

NOTIFY (New Observations Taking Information From Yesterday)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05977413
• Other study ID #: 71202
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: June 2030

Study information

• Verified date: July 2023
• Source: Stanford University
• Contact: David J Maron, MD
• Phone: 650-724-6152
• Email: david.maron[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke as compared with usual care informed by clinical practice guidelines.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40000
• Est. completion date: June 2030
• Est. primary completion date: June 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 84 Years

Eligibility

Inclusion Criteria:

• Age 50-84 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

Related Conditions & MeSH terms

• Atherosclerosis
• Atherosclerotic Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Other:
• Notification of CAC
Provider and patient are notified of coronary artery calcium present on patient's CT scan. Notification includes a personalized image of CAC from the patient's CT scan performed for lung cancer screening.
• Usual Care
Patients randomized to Usual Care will receive usual medical care provided by their clinician informed by widely publicized clinical practice guidelines.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Stanford University	Duke University, Patient-Centered Outcomes Research Institute

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rate of Specific Statin Prescribed and Statin Dose	Rate of prescription of specific statins at specific doses	1 year post randomization
Other	Rate of Prescription of Non-statin Lipid-lowering Medications	Rate of prescription of specific non-statins	1 year post randomization
Other	Rate of Aspirin Prescription	Rate of aspirin prescription by treatment group	1 year post randomization
Other	Number of Antihypertensive Medications	Number of antihypertensive medications prescribed per participant by treatment group	1 year post randomization
Other	Median LDL-C Concentration	Median LDL cholesterol concentration by treatment group	1 year post randomization
Other	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
Other	Systolic blood pressure	Median systolic blood pressure value in mmHg by treatment group	1 year post randomization
Other	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
Other	Body Mass Index	Median body mass index value by treatment group	1 year post randomization
Other	Total number of primary care clinical encounters during the trial		6 years
Other	Number of cardiology encounters		6 years
Other	Number of cardiovascular diagnostic noninvasive tests		6 years
Primary	Time to first occurrence of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke		6 years
Secondary	Rate of All-cause Death	Number (%) of participants in each treatment group with death from any cause.	6 years
Secondary	Rate of Cardiovascular Death	Number (%) of participants in each treatment group with cardiovascular death	6 years
Secondary	Rate of Nonfatal Myocardial Infarction	Number (%) of participants in each treatment group with nonfatal myocardial infarction	6 years
Secondary	Rate of Nonfatal Stroke	Number (%) of participants in each treatment group with nonfatal stroke	6 years
Secondary	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
Secondary	Number of Participants with active lipid-lowering therapy prescriptions	Persistence of need for lipid-lowering therapy at 18 months following randomization.	At 18 months
Secondary	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