EMERALD (Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders)

Phase 4

Completed

• Conditions: Lipid Disorder
• Interventions: Drug: moderate- or high-intensity statin/ rosuvastatin

• Registration Number: NCT05742841
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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

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.

Study Timeline

• Status Verified: 2023-02
• Study First Submitted: 2023-02-15
• Study First Submitted QC: 2023-02-15
• Study First Posted: 2023-02-24
• Study Start: 2023-03-08
• Primary Completion: 2023-06-01
• Study Completion: 2023-07-15
• Results First Submitted: 2024-02-19
• Results First Submitted QC: 2024-03-18
• Results First Posted: 2024-03-20
• Last Update Submitted: 2024-05-16
• Last Update Posted: 2024-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EMERALD protocol	moderate- or high-intensity statin/ rosuvastatin	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

Primary Outcome Measures

Name	Time	Method
Low-density Lipoprotein Cholesterol (LDL-C) Levels at Baseline and Day 30	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.

Trial Locations

Locations (1)

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States