Clinical trial NCT06488105: Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders Trial
Official title: Initiating Preventive Care for Hyperlipidemia in the Emergency Department: The EMERALD (Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders) Trial
Conditions: Lipid Disorder
Hypercholesterolemia
Cardiovascular Diseases
Atherosclerosis
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.
Interventions:
description: moderate- or high-intensity statin (either rosuvastatin 10 mg daily or rosuvastatin 40 mg daily)
name: Statin (rosuvastatin 10 or 40 mg daily, depending on risk)
other_name: Crestor
type: Drug
description: Healthy lifestyle counseling based off the American Heart Association's Life Essential 8 framework
name: Healthy Lifestyle Counseling
type: Behavioral
description: Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders (EMERALD) intervention patients will receive either cardiology or primary care referral (depending on risk level) and usual care patients will receive a primary care referral
name: Outpatient Followup
type: Other
Study arms:
design_group_description: 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.
design_group_title: Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders (EMERALD) arm
design_group_type: Experimental
design_group_description: 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.
design_group_title: Usual Care Arm
design_group_type: Active Comparator
Sponsor: Wake Forest School of Medicine
Collaborators: National Heart, Lung & Blood Institute
National Institutes of Health
Drug name mappings:
name: 瑞舒伐他汀钙
lang: CN
name: Rosuvastatin Calcium
lang: EN
name: ロスバスタチンカルシウム
lang: JP