EMERALD (Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders)

Wake Forest University (WFU)

Status and phase: Completed; Phase 4

Conditions: Lipid Disorder

Treatments: Drug: moderate- or high-intensity statin/ rosuvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT05742841

IRB00091989

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 22 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

EMERALD protocol

Experimental group

Description:

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

Treatment:

Drug: moderate- or high-intensity statin/ rosuvastatin