Investigating the Impact of a Patient-directed Coronary Artery Calcium Score Report: A Randomized-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 7,000
- 主要终点
- Change in LDL Cholesterol
研究概览
简要总结
The goal of this study is to examine if communication of image-based cardiovascular risk to patients undergoing coronary artery calcium scoring (CAC) improves patient understanding of their risk for cardiovascular disease when compared with usual care (physician-only report).
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
- 40 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range: from 40 to 89
- •Referred for CAC at UHHS
排除标准
- •Less than 40 years of age or over 89 years old.
- •Underwent CAC at other locations besides UHHS.
研究组 & 干预措施
Clinical Standard Report Only
Participants referred for Coronary Artery Calcium Score Test that receive clinical standard CAC risk report only.
Clinical Standard Report plus Image-Based Report
Participants referred for Coronary Artery Calcium Score Test that receive clinical standard CAC risk report plus additional image-based report.
干预措施: Image-Based Report (Other)
结局指标
主要结局
Change in LDL Cholesterol
时间窗: baseline-12 months
Change in LDL cholesterol levels obtained from EMR between baseline to 12 months
次要结局
- Change in HDL cholesterol(baseline-12 months)
- Change in Diastolic blood pressure(baseline-12 months)
- Change in HbA1c(baseline-12 months)
- Change in Total Cholesterol(baseline-12 months)
- Change in Triglycerides(baseline-12 months)
- Change in Weight(baseline-12 months)
- Change in Systolic blood pressure(baseline-12 months)
- Stress tests ordered as measured by medical record review - yes/no(12 months)
- Smoking Cessation Visits as measured by medical record review - yes/no(12 months)
- Statin prescriptions written as measured by medical record review - yes/no(12 months)
- Aspirin prescriptions written as measured by medical record review - yes/no(12 months)
研究者
Sanjay Rajagopalan
Assistant Professor of Medicine and Radiology
University Hospitals Cleveland Medical Center