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

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).

Study Overview

• Status: Completed
• Conditions: Lipid Disorder
• Intervention / Treatment: Drug: moderate- or high-intensity statin/ rosuvastatin

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 Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EMERALD protocol; 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; moderate- or high-intensity statin (either rosuvastatin 10mg daily or rosuvastatin 40 mg daily); Other Names: Crestor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Low-density Lipoprotein Cholesterol (LDL-C) Levels at 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.	Baseline and 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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Simon Mahler, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2023
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): July 15, 2023

Study Registration Dates

• First Submitted: February 15, 2023
• First Submitted That Met QC Criteria: February 15, 2023
• First Posted (Actual): February 24, 2023

Study Record Updates

• Last Update Posted (Actual): May 21, 2024
• Last Update Submitted That Met QC Criteria: May 16, 2024
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: cardiovascular disease; hyperlipidemia; atherosclerotic cardiovascular disease
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Disease Attributes; Emergencies; Lipid Metabolism Disorders; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Rosuvastatin Calcium
• Other Study ID Numbers: IRB00091989

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No