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临床试验/NCT04789278
NCT04789278Unknown不适用

Incidental Coronary Calcification Quality Improvement Project

Stanford University2 个研究点 分布在 1 个国家目标入组 173 人开始时间: 2021年3月30日最近更新:
适应症

试验速览

阶段
不适用
入组人数
173
试验地点
2
主要终点
Rate of Statin Prescription

研究概览

简要总结

This is a multi-center, randomized quality improvement project. At least 200 statin-naïve patients without a history of atherosclerotic cardiovascular disease with incidental coronary artery calcium (CAC) on a prior non-gated chest CT will be enrolled across the Stanford Healthcare System and the Palo Alto Veteran's Affairs Healthcare System. Patients will be randomized in a 1:1 fashion to notification or usual care arms. The primary aim of this project is to estimate the increase in 6-month statin prescription among statin-naïve patients without a history of atherosclerotic cardiovascular disease with incidental CAC on a non-gated chest CT who are randomized to receive notification of their findings vs. 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
Other
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

  • Non-gated chest CT between 2014-2019
  • The presence of CAC confirmed by manual review by an experienced radiologist
  • Stanford affiliated primary care provider or endocrinologist for Stanford healthcare system patients and VA primary care provider for VA patients with at least 1 encounter since 2018

排除标准

  • Current or prior statin or PCSK9 inhibitor therapy
  • Prior diagnosis of ASCVD (coronary artery disease, peripheral arterial disease, cerebrovascular disease, coronary/peripheral revascularization)
  • Prior coronary imaging (cardiac CT, invasive coronary angiography)
  • Metastatic cancer or active cancer undergoing chemotherapy
  • History of medical nonadherence

结局指标

主要结局

Rate of Statin Prescription

时间窗: Within 6 months

Proportion of patients prescribed a statin

次要结局

  • Number of primary Care Clinical Encounters(6 months)
  • Number of Cardiology Referrals(6 months)
  • LDL Cholesterol Level(6 months)
  • Systolic Blood Pressure(6 months)
  • Hemoglobin A1c Level(6 months)
  • Statin Intensity(6 months)
  • HDL Cholesterol Level(6 months)
  • Rate of Aspirin Prescription(6 months)
  • Total Cholesterol Level(6 months)
  • Number of Cardiovascular Diagnostic Tests(6 months)
  • Triglyceride Level(6 months)
  • Number of Hypertension Medications(6 months)
  • Body Mass Index(6 months)
  • Pooled cohort equations estimated 10-year risk of atherosclerotic cardiovascular disease(6 months)

研究者

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

Alexander Sandhu

Principal Investigator, Instructor of Medicine, Division of Cardiology

Stanford University

研究点 (2)

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