Ashburn Nicklaus P, Snavely Anna C, Ehrig Molly R, Shapiro Michael D, Herrington David M, Reboussin David M, Gesell Sabina B, Mahler Simon A
From the Department of Emergency Medicine, Wake Forest University School of Medicine (WFUSM), Winston-Salem, NC.
Department of Biostatistics and Data Science, WFUSM, Winston-Salem, NC.
Crit Pathw Cardiol. 2025 Sep 1;24(3):e0390. doi: 10.1097/HPC.0000000000000390. Epub 2025 Apr 28.
Hyperlipidemia (HLD) is a major contributor to atherosclerotic cardiovascular disease (ASCVD). Nearly 30% of emergency department (ED) patients with chest pain have undiagnosed and/or unmanaged HLD, putting them at an increased risk of ASCVD. Although safe and effective HLD treatments exist, the ED traditionally focuses on acute care and does not offer preventive cardiovascular care services. This represents a large, missed opportunity to improve cardiovascular health for the millions of Americans evaluated in the ED each year who are not receiving appropriate preventive care in the outpatient setting. The goals of this study are to determine the efficacy of novel ED-initiated preventive care on lowering cholesterol while also informing our understanding of patient adherence and implementation determinants of ED-initiated preventive cardiovascular care.
We will use a randomized, controlled, parallel-group trial of 130 ED patients being evaluated for acute coronary syndrome at a single site. Participants will be 40-75 years old with prior ASCVD, known diabetes, or 10-year ASCVD risk ≥7.5% who are not already receiving guideline-directed outpatient preventive care. Patients will be randomized with equal probability to EMERALD (Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders) or usual care. Patients in the EMERALD arm will be started on a statin and referred for a 30-day follow-up with cardiology or primary care, depending on the 10-year ASCVD risk level. Usual care arm patients will not be prescribed a statin in the ED and will be asked to follow up with a primary care provider. The primary outcome will be a percent change in low-density lipoprotein cholesterol at 30 days. Secondary outcomes include percent change in low-density lipoprotein cholesterol at 180 days and nonhigh-density lipoprotein cholesterol at 30- and 180 days, the proportion of EMERALD patients who pick up their statin, and the proportion of patients who attend 30-day outpatient follow-up. We will also use mixed methods and semistructured interviews to identify patient adherence facilitators and barriers and implementation determinants for Emergency Medicine providers.
This is the first study to evaluate a novel, protocolized ED-initiated preventive cardiovascular care approach for HLD. If successful, the EMERALD intervention may be able to improve the cardiovascular health for at-risk patients and serve as a use case for other modifiable cardiovascular disease risk factors, such as diabetes, hypertension, tobacco use, and obesity. This single-site study will inform a planned multisite trial.
高脂血症(HLD)是动脉粥样硬化性心血管疾病(ASCVD)的主要促成因素。近30%的急诊科(ED)胸痛患者患有未确诊和/或未得到有效管理的HLD,这使他们面临ASCVD风险增加的问题。尽管存在安全有效的HLD治疗方法,但急诊科传统上侧重于急性护理,不提供预防性心血管护理服务。对于每年在急诊科接受评估但在门诊环境中未接受适当预防性护理的数百万美国人来说,这是一个改善心血管健康的重大错失机会。本研究的目的是确定急诊科启动的新型预防性护理在降低胆固醇方面的疗效,同时增进我们对患者依从性以及急诊科启动的预防性心血管护理实施决定因素的理解。
我们将在一个单一地点对130名因急性冠状动脉综合征接受评估的急诊科患者进行一项随机、对照、平行组试验。参与者年龄在40 - 75岁之间,有既往ASCVD、已知糖尿病或10年ASCVD风险≥7.5%,且尚未接受指南指导的门诊预防性护理。患者将以相等的概率随机分为EMERALD(脂质紊乱的急诊医学心血管风险评估)组或常规护理组。EMERALD组的患者将开始服用他汀类药物,并根据10年ASCVD风险水平转诊至心脏病学或初级保健进行30天随访。常规护理组的患者在急诊科不会被开具他汀类药物,并将被要求随访初级保健提供者。主要结局将是30天时低密度脂蛋白胆固醇的百分比变化。次要结局包括180天时低密度脂蛋白胆固醇以及30天和1八十天时非高密度脂蛋白胆固醇的百分比变化、EMERALD组患者领取他汀类药物的比例以及参加30天门诊随访的患者比例。我们还将使用混合方法和半结构化访谈来确定患者依从性的促进因素和障碍以及急诊医学提供者的实施决定因素。
这是第一项评估针对HLD的新型、标准化的急诊科启动的预防性心血管护理方法的研究。如果成功,EMERALD干预可能能够改善高危患者的心血管健康,并作为其他可改变的心血管疾病风险因素(如糖尿病、高血压、吸烟和肥胖)的一个应用案例。这项单中心研究将为一项计划中的多中心试验提供信息。