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

Initiating Preventive Care for Hyperlipidemia in the Emergency Department: The EMERALD (Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders) Trial

Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders (EMERALD) is a protocolized intervention based on American College of Cardiology/American Heart Association and US Preventive Services Task Force guidelines designed to initiate preventive cardiovascular care for emergency department patients being evaluated for acute coronary syndrome. The overarching goals of this proposal are to (1) determine the efficacy of EMERALD at lowering low-density lipoprotein cholesterol (LDL-C) and non high-density lipoprotein cholesterol (non-HDL-C) among at-risk Emergency Department (ED) patients who are not already receiving guideline-directed outpatient preventive care and (2) inform our understanding of patient adherence and determinants of implementation for ED-based cardiovascular disease prevention strategies.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Atherosclerosis; Hypercholesterolemia; Lipid Disorder
• Intervention / Treatment: Drug: Statin (rosuvastatin 10 or 40 mg daily, depending on risk); Behavioral: Healthy Lifestyle Counseling; Other: Outpatient Followup

Detailed Description

EMERALD involves (1) ordering an ED lipid panel, (2) calculating 10-year atherosclerotic cardiovascular disease (ASCVD) risk, (3) prescribing a moderate- or high-intensity statin, (4) providing healthy lifestyle counseling, and (5) bridging patients to ongoing outpatient preventive care (primary care or cardiology, depending on risk level).

We hypothesize that EMERALD will be associated with lower LDL-C and non-HDL-C at 30- and 180-days vs. usual care. The primary outcome will be percent change in LDL-C at 30-days. Secondary outcomes include percent change in LDL-C at 180-days and non-HDL-C at 30- and 180-days. We will randomize 130 ED patients with possible acute coronary syndrome 1:1 to EMERALD or usual care, which will provide 90% power with a two-sided alpha of 0.05 to demonstrate a 10% difference in percent change in LDL-C at 30-days between arms.

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Lauren Koehler; Phone Number: 336-716-4646; Email: lauren.koehler@advocatehealth.org
• Study Contact Backup: Name: Nick Ashburn; Email: Nicklaus.Ashburn@wfusm.edu

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27517
      • Recruiting
      • Wake Forest University Health Sciences
      • Contact: Lauren Koehler

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

1. Evaluation for Acute Coronary Syndrome
2. Age 40-75 Years
3. 10-year Atherosclerotic Cardiovascular Disease (ASCVD) Risk ≥7.5% or Known Diabetes or

Known ASCVD:

1. Myocardial Infarction
2. Unstable Angina
3. Percutaneous Coronary Intervention
4. Coronary Artery Bypass Graft
5. Stroke
6. Transient Ischemic Attack
7. Peripheral Artery Disease

Exclusion Criteria

1. ST-Segment Elevation Myocardial Infarction (STEMI) Activation
2. ST Depression >1 mm in Contiguous Leads
3. On a Lipid Lowering Agent (Statin, PCSK9 Inhibitor, Bempedoic Acid, Ezetimibe, Inclisiran, etc.)
4. Inability to Return for 30-day Follow-up
5. Unstable Vitals (Systolic blood pressure <90, HR >120 or <50, oxygen saturation <90%)
6. Statin Intolerance
7. Any Resulted High-Sensitivity Troponin I ≥100 ng/L
8. End-stage renal disease (ESRD) and/or glomerular filtration rate (GFR) <30 mL/min/1.73 m2
9. Liver Cirrhosis
10. Pregnancy
11. Anticipated Hospitalization
12. Life Expectancy <1 Year
13. Transfer from Another Hospital
14. Prisoner
15. Non-English Speaking

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders (EMERALD) arm; In the EMERALD arm, care will vary by risk level: (1) patients with known atherosclerotic cardiovascular disease (ASCVD) will qualify for a high-intensity statin (rosuvastatin 40 mg daily) and referral to cardiology for secondary prevention, (2) patients with low-density lipoprotein cholesterol (LDL-C) ≥190 mg/dL will receive a high-intensity statin and a cardiology referral for primary prevention, and (3) for the remaining patients, Emergency Department providers will calculate 10-year ASCVD risk using the Pooled Cohort Equations. These patients will be categorized as (3A) high risk patients (10-year risk ≥20%) who will receive a high-intensity statin and a cardiology referral and (3B) moderate risk patients (10-year risk ≥7.5% but <20% or those with known diabetes and 10-year risk <20%) who will receive a moderate-intensity statin (rosuvastatin 10 mg daily) and a primary care referral. EMERALD patients will also receive healthy lifestyle counseling.	Drug: Statin (rosuvastatin 10 or 40 mg daily, depending on risk); moderate- or high-intensity statin (either rosuvastatin 10 mg daily or rosuvastatin 40 mg daily); Other Names: Crestor; Behavioral: Healthy Lifestyle Counseling; Healthy lifestyle counseling based off the American Heart Association's Life Essential 8 framework; Other: Outpatient Followup; Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders (EMERALD) intervention patients will receive either cardiology or primary care referral (depending on risk level) and usual care patients will receive a primary care referral
Active Comparator: Usual Care Arm; Patients in the usual care arm will receive the current standard of care, which consists of primary care referral and no Emergency Department statin prescription. They will also receive healthy lifestyle counseling.	Behavioral: Healthy Lifestyle Counseling; Healthy lifestyle counseling based off the American Heart Association's Life Essential 8 framework; Other: Outpatient Followup; Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders (EMERALD) intervention patients will receive either cardiology or primary care referral (depending on risk level) and usual care patients will receive a primary care referral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent change in low-density lipoprotein cholesterol (LDL-C) at 30 days	Percent change in LDL-C from the index Emergency Department (ED) encounter through 30 days	Index ED encounter through 30 days (-3, +11 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent change in LDL-C at 180 days.	Percent change in LDL-C from the index ED encounter through 180 days	Index ED encounter through 180 days (+/- 15 days)
Percent change in non high-density lipoprotein cholesterol (non-HDL-C) at 30 days	Percent change in non-HDL-C from the index ED encounter through 30 days	Index ED encounter through 30 days (-3, +11 days)
Percent change in non-HDL-C at 180 days	Percent change in non-HDL-C from the index ED encounter through 180 days	Index ED encounter through 180 days (+/- 15 days)
Proportion of patients with outpatient clinic follow-up at 30 days	Did the patient follow-up with the recommended outpatient care team?	Index ED encounter through 30 days (-3, +8 days)
Proportion of patients with statin prescription pick-up	Did the patient pick-up their statin prescription from the pharmacy?	Index ED encounter through 10 days
Qualitative barriers and facilators	Qualitative interviews to determine facilitators and barriers to the Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders (EMERALD) program	30 days (+30 days) after the index ED encounter

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Nick Ashburn, Nicklaus.Ashburn@wfusm.edu

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2024
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): March 31, 2029

Study Registration Dates

• First Submitted: June 28, 2024
• First Submitted That Met QC Criteria: June 28, 2024
• First Posted (Actual): July 5, 2024

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: cardiovascular disease; hyperlipidemia; atherosclerotic cardiovascular disease
• Additional Relevant MeSH Terms: Vascular Diseases; Metabolic Diseases; Dyslipidemias; Arteriosclerosis; Arterial Occlusive Diseases; Nutritional and Metabolic Diseases; Cardiovascular Diseases; Hypercholesterolemia; Atherosclerosis; Lipid Metabolism Disorders; Hyperlipidemias; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Hydrocarbons; Amides; Pyrimidines; Hydrocarbons, Halogenated; Sulfonamides; Sulfones; Fluorobenzenes; Hydrocarbons, Fluorinated; Rosuvastatin Calcium; Hydroxymethylglutaryl-CoA Reductase Inhibitors
• Other Study ID Numbers: IRB00104057; 1K23HL169929-01A1 (U.S. NIH Grant/Contract)

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.: Yes