Atherosclerotic Cardiovascular Disease
Conditions
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.
Interventions
OTHERCAC 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.
OTHERClinician 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.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
50 Years to 84 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first occurrence of death, nonfatal myocardial infarction, or nonfatal stroke | 6 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of All-cause Death | 6 years | Number (%) of participants in each treatment group with death from any cause. |
| Rate of Cardiovascular Death | 6 years | Number (%) of participants in each treatment group with cardiovascular death |
| Rate of Nonfatal Myocardial Infarction | 6 years | Number (%) of participants in each treatment group with nonfatal myocardial infarction |
| Rate of Nonfatal Stroke | 6 years | Number (%) of participants in each treatment group with nonfatal stroke |
| 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. |
| 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) |
Contacts
PRINCIPAL_INVESTIGATORDavid J Maron, MD
Stanford University
Outcome results
None listed