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临床试验/NCT05394181
NCT05394181Unknown不适用

Notify 2: An Evaluation of the Impact of Notification of Incidental Coronary Artery Calcium on Statin Rates

Stanford University2 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2022年8月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
600
试验地点
2
主要终点
Statin prescription rate

研究概览

简要总结

The primary objective is to estimate the impact of notification of primary care provider and patient of at least moderate incidental coronary artery calcification (CAC) on a prior non-gated chest CT on statin prescription rates at 4 months among patients without a clinical history of atherosclerotic cardiovascular disease not actively on statin therapy. This study will determine if notifying patients and their primary care clinician about an existing finding will influence shared decision-making around statins between patients and their primary care clinician.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age greater than or equal to 18 and less than 85
  • Non-gated chest CT from 1/1/2016-6/30/2020 with algorithm screening estimating CAC score of at least 100 Agatston Units with radiologist confirmation of moderate or severe CAC
  • Encounter with Palo Alto VA affiliated primary care since 2020

排除标准

  • Prior diagnosis of coronary artery disease, peripheral artery disease, or cerebrovascular disease
  • Metastatic cancer or active cancer undergoing chemotherapy
  • CT coronary angiogram since 2016
  • Invasive Coronary angiogram since 2016
  • CAC scan since 2016
  • Statin therapy within prior 6 months
  • Prior ezetimibe or PCSK9 inhibitor therapy
  • Prior rhabdomyolysis with statin therapy
  • Schizophrenia
  • Substance abuse disorder (alcohol, amphetamines, cocaine, opioids)

结局指标

主要结局

Statin prescription rate

时间窗: 4 months

Prescription of statin medication

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alexander Sandhu

Instructor of Medicine

Stanford University

研究点 (2)

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