NOTIFY-OUTCOMES (New Observations Taking Information From Yesterday)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 40,000
- 主要终点
- Time to first occurrence of death, nonfatal myocardial infarction, or nonfatal stroke
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
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.
干预措施: CAC Notification (Other)
Clinician 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.
干预措施: Clinician Guideline Reminder (Other)
结局指标
主要结局
Time to first occurrence of death, nonfatal myocardial infarction, or nonfatal stroke
时间窗: 6 years
次要结局
- Rate of Cardiovascular Death(6 years)
- Rate of Nonfatal Myocardial Infarction(6 years)
- Rate of Nonfatal Stroke(6 years)
- Number of revascularization procedures (PCI, CABG, carotid artery revascularization, or peripheral artery revascularization)(6 years)
- Rate of All-cause Death(6 years)
- Initial lipid-lowering therapy prescription rate(within 6 months of 1st notification)
- Number of Participants with active lipid-lowering therapy prescriptions(At 18 months)
研究者
David Maron
Professor of Medicine
Stanford University