EMERALD (Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Low-density Lipoprotein Cholesterol (LDL-C) Levels at Baseline and Day 30
研究概览
简要总结
The EMERALD intervention involves 1) ordering an Emergency Department (ED) lipid panel, 2) calculating 10-year Atherosclerotic cardiovascular disease (ASCVD) risk using the Pooled Cohort Equations, 3) prescribing a moderate- or high-intensity statin if applicable, and 4) referring patients to outpatient care (primary care, preventive cardiology, or general cardiology, depending on risk level).
详细描述
EMERALD (Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders) is a pilot study seeking to determine the feasibility of initiating medical therapy for hyperlipidemia (HLD) in the Emergency Department (ED) and will collect data essential to inform a future randomized controlled trial comparing ED HLD treatment to usual care. HLD is a key cardiovascular disease (CVD) risk factor that is causally associated with atherosclerotic cardiovascular disease (ASCVD), the leading cause of US mortality and morbidity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Emergency Department (ED) patients with chest pain
- •40-75 years old
- •a low-density lipoprotein cholesterol (LDL-C) ≥70 mg/dL on an ED lipid panel or have known diabetes or Atherosclerotic Cardiovascular Disease (ASCVD)
排除标准
- •Subject unwilling to take study medication
- •Pregnancy or breastfeeding
- •Inability to take study medication or, in the opinion of the Investigators/subject's doctors unsuitable for study participation
- •ST-Segment Elevation Myocardial Infarction (STEMI) Activation
- •ST-Segment Depression >1 mm
- •On a Lipid Lowering Agent (Statin, PCSK9 Inhibitor, Bempedoic Acid, Ezetimibe, Inclisiran)
- •Unstable Vitals (Blood Pressure (BP) <90, Heart Rate (HR) >120 or <50, O2 sat <90%)
- •Statin Intolerance
- •High-sensitivity Troponin I ≥100 ng/L
- •End-Stage Renal Disease (ESRD) and/or glomerular filtration rate (GFR) <30 mL/min/1.73 m2
- •Liver Cirrhosis
- •Hospitalization
- •Life Expectancy <1 Year
- •Transfer from Another Hospital
- •Non-English Speaking
研究组 & 干预措施
EMERALD protocol
- ordering a lipid panel during the index ED encounter and 30-days (+/- 5 business days) after ED discharge, 2) completion of the Pooled Cohort Equations by the patient's ED provider at the index visit, and 3) starting medical therapy (moderate- or high-intensity statin/ rosuvastatin) in the ED
干预措施: moderate- or high-intensity statin/ rosuvastatin (Drug)
结局指标
主要结局
Low-density Lipoprotein Cholesterol (LDL-C) Levels at Baseline and Day 30
时间窗: Baseline and Day 30
A lipid panel is a common blood test that healthcare providers use to monitor and screen for risk of cardiovascular disease. The panel includes three measurements of your cholesterol levels and a measurement of your triglycerides.
次要结局
未报告次要终点