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EMERALD (Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders) (EMERALD)

Primary Purpose

Lipid Disorder

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
moderate- or high-intensity statin/ rosuvastatin
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lipid Disorder focused on measuring hyperlipidemia, cardiovascular disease, atherosclerotic cardiovascular disease

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wake Forest University Health Sciences

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EMERALD protocol

Arm Description

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

Outcomes

Primary Outcome Measures

(low-density lipoprotein cholesterol) LDL-C levels
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.
(low-density lipoprotein cholesterol) LDL-C levels
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.

Secondary Outcome Measures

Change in non-high-density lipoprotein cholesterol (non-HDL-C) levels
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.

Full Information

First Posted
February 15, 2023
Last Updated
September 7, 2023
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05742841
Brief Title
EMERALD (Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders)
Acronym
EMERALD
Official Title
EMERALD (Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
March 8, 2023 (Actual)
Primary Completion Date
June 1, 2023 (Actual)
Study Completion Date
July 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lipid Disorder
Keywords
hyperlipidemia, cardiovascular disease, atherosclerotic cardiovascular disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
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
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EMERALD protocol
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
moderate- or high-intensity statin/ rosuvastatin
Other Intervention Name(s)
Crestor
Intervention Description
moderate- or high-intensity statin (either rosuvastatin 10mg daily or rosuvastatin 40 mg daily)
Primary Outcome Measure Information:
Title
(low-density lipoprotein cholesterol) LDL-C levels
Description
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.
Time Frame
Baseline
Title
(low-density lipoprotein cholesterol) LDL-C levels
Description
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.
Time Frame
Day 30
Secondary Outcome Measure Information:
Title
Change in non-high-density lipoprotein cholesterol (non-HDL-C) levels
Description
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.
Time Frame
Baseline and Day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon Mahler, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

EMERALD (Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders)

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