EMERALD (Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders) (EMERALD)
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).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
North Carolina
-
Winston-Salem, North Carolina, United States, 27157
- Wake Forest University Health Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: EMERALD protocol
1) ordering a lipid panel during the index ED encounter and 30-days (+/- 5 business days) after ED discharge, 2) completion of the Pooled Cohort Equations by the patient's ED provider at the index visit, and 3) starting medical therapy (moderate- or high-intensity statin/ rosuvastatin) in the ED |
moderate- or high-intensity statin (either rosuvastatin 10mg daily or rosuvastatin 40 mg daily)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
Baseline and Day 30
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Simon Mahler, MD, Wake Forest University Health Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Vascular Diseases
- Metabolic Diseases
- Dyslipidemias
- Arteriosclerosis
- Arterial Occlusive Diseases
- Nutritional and Metabolic Diseases
- Cardiovascular Diseases
- Atherosclerosis
- Lipid Metabolism Disorders
- Hyperlipidemias
- Sulfur Compounds
- Organic Chemicals
- Heterocyclic Compounds, 1-Ring
- Heterocyclic Compounds
- Hydrocarbons
- Amides
- Pyrimidines
- Hydrocarbons, Halogenated
- Sulfonamides
- Sulfones
- Fluorobenzenes
- Hydrocarbons, Fluorinated
- Rosuvastatin Calcium
Other Study ID Numbers
- IRB00091989
- 1K23HL169929-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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