Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders Trial
- Conditions
- Cardiovascular DiseasesAtherosclerosisLipid DisorderHypercholesterolemia
- Interventions
- Behavioral: Healthy Lifestyle CounselingDrug: Statin (rosuvastatin 10 or 40 mg daily, depending on risk)Other: Outpatient Followup
- Registration Number
- NCT06488105
- Lead Sponsor
- Wake Forest University Health Sciences
- Brief 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.
- Detailed Description
EMERALD involves (1) ordering an ED lipid panel, (2) calculating 10-year atherosclerotic cardiovascular disease (ASCVD) risk, (3) prescribing a moderate- or high-intensity statin, (4) providing healthy lifestyle counseling, and (5) bridging patients to ongoing outpatient preventive care (primary care or cardiology, depending on risk level).
We hypothesize that EMERALD will be associated with lower LDL-C and non-HDL-C at 30- and 180-days vs. usual care. The primary outcome will be percent change in LDL-C at 30-days. Secondary outcomes include percent change in LDL-C at 180-days and non-HDL-C at 30- and 180-days. We will randomize 130 ED patients with possible acute coronary syndrome 1:1 to EMERALD or usual care, which will provide 90% power with a two-sided alpha of 0.05 to demonstrate a 10% difference in percent change in LDL-C at 30-days between arms.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 130
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders (EMERALD) arm Outpatient Followup 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. Usual Care Arm Healthy Lifestyle Counseling 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. Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders (EMERALD) arm Healthy Lifestyle Counseling 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. Usual Care Arm Outpatient Followup 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. Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders (EMERALD) arm Statin (rosuvastatin 10 or 40 mg daily, depending on risk) 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.
- Primary Outcome Measures
Name Time Method Percent change in low-density lipoprotein cholesterol (LDL-C) at 30 days Index ED encounter through 30 days (-3, +11 days) Percent change in LDL-C from the index Emergency Department (ED) encounter through 30 days
- Secondary Outcome Measures
Name Time Method Qualitative barriers and facilators 30 days (+30 days) after the index ED encounter Qualitative interviews to determine facilitators and barriers to the Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders (EMERALD) program
Percent change in LDL-C at 180 days. Index ED encounter through 180 days (+/- 15 days) Percent change in LDL-C from the index ED encounter through 180 days
Percent change in non-HDL-C at 180 days Index ED encounter through 180 days (+/- 15 days) Percent change in non-HDL-C from the index ED encounter through 180 days
Proportion of patients with outpatient clinic follow-up at 30 days Index ED encounter through 30 days (-3, +8 days) Did the patient follow-up with the recommended outpatient care team?
Percent change in non high-density lipoprotein cholesterol (non-HDL-C) at 30 days Index ED encounter through 30 days (-3, +11 days) Percent change in non-HDL-C from the index ED encounter through 30 days
Proportion of patients with statin prescription pick-up Index ED encounter through 10 days Did the patient pick-up their statin prescription from the pharmacy?
Trial Locations
- Locations (1)
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States