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The trial was never started because it was not funded.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient-Clinician CAC Notification | Experimental | 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. |
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| Clinician Guideline Reminder | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAC Notification | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first occurrence of death, nonfatal myocardial infarction, or nonfatal stroke | 6 years |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David J Maron, MD | Stanford University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36342823 | Background | 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. | |
| 34075194 |
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| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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|
| Clinician Guideline Reminder | Other | 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. |
|
| 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 |
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 |
| 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. |