RecruitingPhase 2NCT06488105

Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders Trial

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

Sponsor

Wake Forest University Health Sciences

Enrollment

130 participants

Start Date

Aug 5, 2024

Study Type

INTERVENTIONAL

Conditions

Cardiovascular Diseases Atherosclerosis Lipid Disorder Hypercholesterolemia

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.

Eligibility

Min Age: 40 YearsMax Age: 75 Years

Inclusion Criteria11

Evaluation for Acute Coronary Syndrome
Age 40-75 Years
10-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

Exclusion Criteria15

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

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Interventions

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

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

BEHAVIORALHealthy Lifestyle Counseling

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

OTHEROutpatient 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