EMERALD (Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders)

NCT05742841 | Completed Phase 4 Results FDA Drug

• 1 other identifier: IRB00091989
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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).

Conditions

Lipid Disorder

Keywords

hyperlipidemia; cardiovascular disease; atherosclerotic cardiovascular disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

EMERALD protocol

EXPERIMENTAL

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

Drug: moderate- or high-intensity statin/ rosuvastatin

Interventions

moderate- or high-intensity statin/ rosuvastatin DRUG

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

Also known as: Crestor

EMERALD protocol

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Emergency Department (ED) patients with chest pain
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Lipid Metabolism Disorders; Hyperlipidemias; Cardiovascular Diseases; Atherosclerosis

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases; Dyslipidemias; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Nick Ashburn
• Organization: Wake Forest School of Medicine

n.ashburn@wakehealth.edu

336-716-4646

Study Officials

• Simon Mahler, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: February 15, 2023
• First Posted: February 24, 2023
• Study Start: March 8, 2023
• Primary Completion: June 1, 2023
• Study Completion: July 15, 2023
• Last Updated: May 21, 2024
• Results First Posted: March 20, 2024

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)