Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders Trial

NCT06488105 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: IRB001040571K23HL169929-01A1
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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

Keywords

hyperlipidemia; cardiovascular disease; atherosclerotic cardiovascular disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Percent change in LDL-C at 180 days.

  Index ED encounter through 180 days (+/- 15 days)

• Percent change in non high-density lipoprotein cholesterol (non-HDL-C) at 30 days

  Index ED encounter through 30 days (-3, +11 days)

• Percent change in non-HDL-C at 180 days

  Index ED encounter through 180 days (+/- 15 days)

• Proportion of patients with outpatient clinic follow-up at 30 days

  Index ED encounter through 30 days (-3, +8 days)

• Proportion of patients with statin prescription pick-up

  Index ED encounter through 10 days

Study Arms (2)

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

EXPERIMENTAL

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); Behavioral: Healthy Lifestyle Counseling; Other: Outpatient Followup

Usual Care Arm

ACTIVE COMPARATOR

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; Other: Outpatient Followup

Interventions

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

moderate- or high-intensity statin (either rosuvastatin 10 mg daily or rosuvastatin 40 mg daily)

Also known as: Crestor

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

Healthy Lifestyle Counseling BEHAVIORAL

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

Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders (EMERALD) arm; Usual Care Arm

Outpatient Followup OTHER

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

Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders (EMERALD) arm; Usual Care Arm

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Evaluation for Acute Coronary Syndrome
• Age 40-75 Years
• year Atherosclerotic Cardiovascular Disease (ASCVD) Risk ≥7.5% or Known Diabetes or
• Known ASCVD:
• Myocardial Infarction
• Unstable Angina
• Percutaneous Coronary Intervention
• Coronary Artery Bypass Graft
• Stroke
• Transient Ischemic Attack
• Peripheral Artery Disease

You may not qualify if:

• ST-Segment Elevation Myocardial Infarction (STEMI) Activation
• ST Depression \>1 mm in Contiguous Leads
• On a Lipid Lowering Agent (Statin, PCSK9 Inhibitor, Bempedoic Acid, Ezetimibe, Inclisiran, etc.)
• Inability to Return for 30-day Follow-up
• Unstable Vitals (Systolic blood pressure \<90, HR \>120 or \<50, oxygen saturation \<90%)
• Statin Intolerance
• Any Resulted 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
• Pregnancy
• Anticipated Hospitalization
• Life Expectancy \<1 Year
• Transfer from Another Hospital
• Prisoner
• Non-English Speaking

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27517, United States

RECRUITING

MeSH Terms

Conditions

Lipid Metabolism Disorders; Hypercholesterolemia; Cardiovascular Diseases; Atherosclerosis; Hyperlipidemias

Interventions

Hydroxymethylglutaryl-CoA Reductase Inhibitors; Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases; Dyslipidemias; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses; Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Nick Ashburn

  Nicklaus.Ashburn@wfusm.edu

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lauren Koehler

CONTACT

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

Nick Ashburn

CONTACT

Nicklaus.Ashburn@wfusm.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 130 Emergency Department patients will be randomized with chest pain 1:1 to Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders (EMERALD) or usual care.

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 5, 2024
• Study Start: August 5, 2024
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): March 31, 2029
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)