Clinical trial NCT05977413: NOTIFY (New Observations Taking Information From Yesterday)
Official title: NOTIFY-OUTCOMES (New Observations Taking Information From Yesterday)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Atherosclerotic Cardiovascular Disease
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Duke University
name: Patient-Centered Outcomes Research Institute
First posted: 2023-08-04
Enrollment: 40000
Sex: ALL
Minimum age (years): 50
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time to first occurrence of death, nonfatal myocardial infarction, or nonfatal stroke
timeFrame: 6 years
Secondary outcomes:
measure: Rate of All-cause Death
timeFrame: 6 years
measure: Rate of Cardiovascular Death
timeFrame: 6 years
measure: Rate of Nonfatal Myocardial Infarction
timeFrame: 6 years
measure: Rate of Nonfatal Stroke
timeFrame: 6 years
measure: Initial lipid-lowering therapy prescription rate
timeFrame: within 6 months of 1st notification
measure: Number of Participants with active lipid-lowering therapy prescriptions
timeFrame: At 18 months
measure: Number of revascularization procedures (PCI, CABG, carotid artery revascularization, or peripheral artery revascularization)
timeFrame: 6 years
Other outcomes:
measure: Rate of Specific Statin Prescribed and Statin Dose
timeFrame: 1 year post randomization
measure: Rate of Prescription of Non-statin Lipid-lowering Medications
timeFrame: 1 year post randomization
measure: Rate of Aspirin Prescription
timeFrame: 1 year post randomization
measure: Number of Antihypertensive Medications
timeFrame: 1 year post randomization
measure: Median LDL-C Concentration
timeFrame: 1 year post randomization
measure: Percentage of participants with LDL-C <70 mg/dL
timeFrame: 1 year post randomization
measure: Systolic blood pressure
timeFrame: 1 year post randomization
measure: Percentage of participants with Systolic Blood Pressure <130 mmHg
timeFrame: 1 year post randomization
measure: Body Mass Index
timeFrame: 1 year post randomization
measure: Total number of primary care clinical encounters during the trial
timeFrame: 6 years
measure: Number of cardiology encounters
timeFrame: 6 years
measure: Number of cardiovascular diagnostic noninvasive tests
timeFrame: 6 years
Locations:
Study officials:
affiliation: Stanford University
name: David J Maron, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.