Recruiting
Phase 2

EMERALD

Sponsor:

Wake Forest University Health Sciences

Code:

NCT06488105

Conditions

Lipid Disorder

Hypercholesterolemia

Cardiovascular Diseases

Atherosclerosis

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Statin (rosuvastatin 10 or 40 mg daily, depending on risk)

Healthy Lifestyle Counseling

Outpatient Followup

Study Details

Brief summary:

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.

Conditions

Lipid Disorder

Hypercholesterolemia

Cardiovascular Diseases

Atherosclerosis

Study ID

NCT06488105

Start date

Aug 5, 2024

Status verified date

Feb, 2026

Completion date

Mar 31, 2029

Anticipated

Primary completion date

Nov 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

130 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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)

Healthy Lifestyle Counseling

Healthy lifestyle counseling based off the American Heart Association's Life Essential 8 framework

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

Primary outcome measure

  • Percent change in low-density lipoprotein cholesterol (LDL-C) at 30 days [ Time Frame: Index ED encounter through 30 days (-3, +11 days) ]

Central Contacts and Locations

Central contacts

Lauren Koehler

336-716-4646Lauren.Koehler@Advocatehealth.org

Nick Ashburn

Nicklaus.Ashburn@wfusm.edu

Locations

Wake Forest University Health Sciences

Recruiting

Winston-Salem, North Carolina, United States, 27517

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Keywords

  • hyperlipidemia
  • cardiovascular disease
  • atherosclerotic cardiovascular disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-02-27.