EMERALD (Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders)

The EMERALD intervention involves 1) ordering an Emergency Department (ED) lipid panel, 2) calculating 10-year Atherosclerotic cardiovascular disease (ASCVD) risk using the Pooled Cohort Equations, 3) prescribing a moderate- or high-intensity statin if applicable, and 4) referring patients to outpatient care (primary care, preventive cardiology, or general cardiology, depending on risk level).

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Key information

Conditions

Lipid Disorder Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

About this study

EMERALD (Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders) is a pilot study seeking to determine the feasibility of initiating medical therapy for hyperlipidemia (HLD) in the Emergency Department (ED) and will collect data essential to inform a future randomized controlled trial comparing ED HLD treatment to usual care. HLD is a key cardiovascular disease (CVD) risk factor that is causally associated with atherosclerotic cardiovascular disease (ASCVD), the leading cause of US mortality and morbidity.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Emergency Department (ED) patients with chest pain
40-75 years old
a low-density lipoprotein cholesterol (LDL-C) ≥70 mg/dL on an ED lipid panel or have known diabetes or Atherosclerotic Cardiovascular Disease (ASCVD)

Exclusion criteria

Subject unwilling to take study medication
Pregnancy or breastfeeding
Inability to take study medication or, in the opinion of the Investigators/subject's doctors unsuitable for study participation
ST-Segment Elevation Myocardial Infarction (STEMI) Activation
ST-Segment Depression >1 mm
On a Lipid Lowering Agent (Statin, PCSK9 Inhibitor, Bempedoic Acid, Ezetimibe, Inclisiran)
Unstable Vitals (Blood Pressure (BP) <90, Heart Rate (HR) >120 or <50, O2 sat <90%)
Statin Intolerance
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
Hospitalization
Life Expectancy <1 Year
Transfer from Another Hospital
Prisoner
Non-English Speaking

Treatment and study plan

moderate- or high-intensity statin/ rosuvastatin

Drug

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

Other names: Crestor

Primary outcomes

Low-density Lipoprotein Cholesterol (LDL-C) Levels at Baseline and Day 30

Time frame: Baseline and Day 30

A lipid panel is a common blood test that healthcare providers use to monitor and screen for risk of cardiovascular disease. The panel includes three measurements of your cholesterol levels and a measurement of your triglycerides.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Acronym: EMERALD

Important dates

Study start: 2023
Primary completion: 2023
Study completion: 2023
First posted: Feb 24, 2023
Registry last updated: May 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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