EMERALD (Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders)

Sponsor

Wake Forest University Health Sciences (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05742841

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Lipid Disorder	Drug: moderate- or high-intensity statin/ rosuvastatin	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

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 ED20 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)

Primary Purpose:

Prevention

Official Title:

EMERALD (Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders)

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EMERALD protocol 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 moderate- or high-intensity statin (either rosuvastatin 10mg daily or rosuvastatin 40 mg daily) Other Names: Crestor

Arm

Intervention/Treatment

Experimental: EMERALD protocol

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

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

Other Names:

Crestor

Outcome Measures

Primary Outcome Measures

(low-density lipoprotein cholesterol) LDL-C levels [Baseline]
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 [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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wake Forest University Health Sciences	Winston-Salem	North Carolina	United States	27157

Sponsors and Collaborators

Wake Forest University Health Sciences

Investigators

Principal Investigator: Simon Mahler, MD, Wake Forest University Health Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Wake Forest University Health Sciences

ClinicalTrials.gov Identifier:

NCT05742841

Other Study ID Numbers:

IRB00091989

First Posted:

Feb 24, 2023

Last Update Posted:

Feb 24, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Wake Forest University Health Sciences

hyperlipidemia

cardiovascular disease

atherosclerotic cardiovascular disease

Additional relevant MeSH terms:

Lipid Metabolism Disorders

Emergencies

Rosuvastatin Calcium

Study Results

No Results Posted as of Feb 24, 2023