EMERALD (Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders)

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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EMERALD (Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders)

Conditions
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Lipid Disorder

Intervention / Treatment
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* Drug: moderate- or high-intensity statin/ rosuvastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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 Prisoner Non-English Speaking

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: 20 patients designed to assess the feasibility of Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders (EMERALD) and to explore changes in low-density lipoprotein-cholesterol (LDL-C) by initiating medical therapy in the ED
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EMERALD protocol<br>1) 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 | Drug: moderate- or high-intensity statin/ rosuvastatin<br>* moderate- or high-intensity statin (either rosuvastatin 10mg daily or rosuvastatin 40 mg daily)<br>* Other names: Crestor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| (low-density lipoprotein cholesterol) LDL-C levels | 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. | Baseline | 
| (low-density lipoprotein cholesterol) LDL-C levels | 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. | Day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in non-high-density lipoprotein cholesterol (non-HDL-C) levels | 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. | Baseline and Day 30 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hyperlipidemia, cardiovascular disease, atherosclerotic cardiovascular disease