NOTIFY (New Observations Taking Information From Yesterday)
- Conditions
- Atherosclerotic Cardiovascular Disease
- Interventions
- Other: Notification of CACOther: Usual Care
- 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
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 40000
- 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)
- 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
- Arm && Interventions
Group Intervention Description Notification of CAC Notification of CAC For patients randomized to the notification of CAC arm (NC), primary clinicians will be notified that with the assistance of a deep-learning algorithm, one of their patients was found to have a CAC score \>100 AU. The notification will include an image taken from the CT scan with CAC clearly marked. The notification will also include American Heart Association/American College of Cardiology 2a recommendation to initiate lipid lowering therapy (usually statin) given the presence of moderate-severe CAC. Patients randomized to notification will receive messages (via EHR portal-based messages, text, or US postal mail) with notification of CAC presence on their LDCT, images showing the presence of CAC from their previous chest CT clearly marked, the recommendation to discuss statin or other lipid-lowering therapy with their clinician, and a link to a patient-friendly website about CAC and risk factor control. There will be reminder messages sent at 3 weeks and 12 months. Usual Care Usual Care Patients randomized to Usual Care will receive usual medical care provided by their clinician informed by widely publicized clinical practice guidelines.
- 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 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
Rate of Cardiovascular Death 6 years Number (%) of participants in each treatment group with cardiovascular death
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.