Phase 4
N=22
EMERALD (Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders)
Lipid Disorder
Bottom Line
View on ClinicalTrials.gov: NCT05742841 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: Low-density Lipoprotein Cholesterol (LDL-C) Levels at Baseline and Day 30 — 110; 84.0 mg/dL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- moderate- or high-intensity statin/ rosuvastatin (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Low-density Lipoprotein Cholesterol (LDL-C) Levels at Baseline and Day 30 |
110; 84.0 | — |
Summary
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).
Eligibility Criteria
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) 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
Data sourced from ClinicalTrials.gov (NCT05742841). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.