Notification of Incidental Coronary Artery Calcium in Patients With Atherosclerotic Cardiovascular Disease (NOTIFY-ASCVD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 233
- 试验地点
- 2
- 主要终点
- Initiation of lipid-lowering therapy
研究概览
简要总结
Estimate the impact of notifying both patients and their clinicians of the presence of incidental coronary artery calcium (CAC) on initiation of lipid-lowering therapy in patients with ASCVD who are not receiving lipid-lowering therapy.
详细描述
This is a randomized quality improvement (QI) project evaluating the impact of notifying patients and their clinicians (primary care, cardiologists, neurologists, or vascular surgeon) of incidental CAC detected on a prior chest CT scan. Patients will be identified by screening previous non-gated chest CT scans and electronic health records. The presence of CAC will be confirmed by a radiologist. Eligible patients will be randomized to: 1) notification of presence of CAC with a CT scan image; 2) notification of presence of CAC without a CT scan image; 3) or usual care.
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
- Double (Participant, Care Provider)
盲法说明
In the usual care arm, patients or clinicians will not be notified.
入排标准
- 年龄范围
- 18 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of CAC on non-gated chest CT scans performed from 2021 to 2025
- •Age <85 years
- •Diagnosis of ASCVD(coronary artery disease, peripheral artery disease, or cerebrovascular disease)
- •Visit to Stanford affiliated clinician since 2022 at one of the following Stanford clinics including University affiliated clinics:
- •Internal Medicine
- •Family Medicine
- •Vascular surgery
- •Primary language is English or Spanish
排除标准
- •No diagnosis of ASCVD
- •Patients receiving lipid-lowering therapy
- •Metastatic cancer or active cancer undergoing chemotherapy
研究组 & 干预措施
Notification with a CAC image
Notification of presence of CAC with a CT scan image and the ACC/AHA guideline recommendation for initiation of lipid-lowering therapy.
干预措施: Notification of patients and clinicians (Other)
Notification without a CAC image
Notification of presence of CAC without a CT scan image and the ACC/AHA guideline recommendation for initiation of lipid-lowering therapy.
干预措施: Notification of patients and clinicians (Other)
Usual care
The usual care arm will not receive any additional notification beyond the standard of care. If the intervention is successful, we will notify patients in the usual care arm of the presence of CAC and the ACC/AHA guideline recommendation for initiation of lipid-lowering therapy.
结局指标
主要结局
Initiation of lipid-lowering therapy
时间窗: Month 6
Number of patients who had initiation of lipid-lowering therapy
次要结局
未报告次要终点
研究者
Fatima Rodriguez
Associate Professor of Medicine (Cardiovascular Medicine)
Stanford University