Clinical trial NCT05742841: EMERALD (Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders)
Official title: EMERALD (Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lipid Disorder
Keywords: hyperlipidemia
cardiovascular disease
atherosclerotic cardiovascular disease
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2023-02-24
Enrollment: 22
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 20 patients designed to assess the feasibility of Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders (EMERALD) and to explore changes in low-density lipoprotein-cholesterol (LDL-C) by initiating medical therapy in the ED
Primary purpose: PREVENTION

Brief 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).

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.

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) \<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

Primary outcomes:
measure: Low-density Lipoprotein Cholesterol (LDL-C) Levels at Baseline and Day 30
timeFrame: Baseline and Day 30
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Simon Mahler, MD
role: PRINCIPAL_INVESTIGATOR
References: