Initiating Preventive Care for Hyperlipidemia in the Emergency Department: The EMERALD (Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders) Trial

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Other, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders (EMERALD) is a protocolized intervention based on American College of Cardiology/American Heart Association and US Preventive Services Task Force guidelines designed to initiate preventive cardiovascular care for emergency department patients being evaluated for acute coronary syndrome. The overarching goals of this proposal are to (1) determine the efficacy of EMERALD at lowering low-density lipoprotein cholesterol (LDL-C) and non high-density lipoprotein cholesterol (non-HDL-C) among at-risk Emergency Department (ED) patients who are not already receiving guideline-directed outpatient preventive care and (2) inform our understanding of patient adherence and determinants of implementation for ED-based cardiovascular disease prevention strategies.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 75
Healthy Volunteers: f
View:

• Evaluation for Acute Coronary Syndrome

• Age 40-75 Years

• 10-year Atherosclerotic Cardiovascular Disease (ASCVD) Risk ≥7.5% or Known Diabetes or

⁃ Known ASCVD:

• Myocardial Infarction

• Unstable Angina

• Percutaneous Coronary Intervention

• Coronary Artery Bypass Graft

• Stroke

• Transient Ischemic Attack

• Peripheral Artery Disease

Locations
United States
North Carolina
Wake Forest University Health Sciences
RECRUITING
Winston-salem
Contact Information
Primary
Lauren Koehler
lekoehle@wakehealth.edu
336-716-4646
Backup
Nick Ashburn
n.ashburn@wakehealth.edu
Time Frame
Start Date: 2024-08-05
Estimated Completion Date: 2029-03-31
Participants
Target number of participants: 130
Treatments
Experimental: Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders (EMERALD) arm
In the EMERALD arm, care will vary by risk level: (1) patients with known atherosclerotic cardiovascular disease (ASCVD) will qualify for a high-intensity statin (rosuvastatin 40 mg daily) and referral to cardiology for secondary prevention, (2) patients with low-density lipoprotein cholesterol (LDL-C) ≥190 mg/dL will receive a high-intensity statin and a cardiology referral for primary prevention, and (3) for the remaining patients, Emergency Department providers will calculate 10-year ASCVD risk using the Pooled Cohort Equations. These patients will be categorized as (3A) high risk patients (10-year risk ≥20%) who will receive a high-intensity statin and a cardiology referral and (3B) moderate risk patients (10-year risk ≥7.5% but \<20% or those with known diabetes and 10-year risk \<20%) who will receive a moderate-intensity statin (rosuvastatin 10 mg daily) and a primary care referral. EMERALD patients will also receive healthy lifestyle counseling.
Active_comparator: Usual Care Arm
Patients in the usual care arm will receive the current standard of care, which consists of primary care referral and no Emergency Department statin prescription. They will also receive healthy lifestyle counseling.
Sponsors
Collaborators: National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
Leads: Wake Forest University Health Sciences

This content was sourced from clinicaltrials.gov