EMERALD (Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders)

Lipid Disorder Clinical Trial

— EMERALD  

Official title:

EMERALD (Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05742841
• Other study ID #: IRB00091989
• Status: Completed
• Phase: Phase 4
• Start date: March 8, 2023
• Est. completion date: July 15, 2023

Study information

• Verified date: February 2023
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: July 15, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Lipid Disorder
• Lipid Metabolism Disorders

Intervention

Drug:
• moderate- or high-intensity statin/ rosuvastatin
moderate- or high-intensity statin (either rosuvastatin 10mg daily or rosuvastatin 40 mg daily)

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Low-density Lipoprotein Cholesterol (LDL-C) Levels at 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