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Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders Trial

Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders Trial

Recruiting
40-75 years
All
Phase 2

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Overview

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.

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.

Eligibility

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 details
    Lipid Disorder
    Hypercholesterolemia
    Cardiovascular Diseases
    Atherosclerosis

NCT06488105

Wake Forest University Health Sciences

16 October 2025

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