Atherosclerosis, Cardiovascular Diseases, Hypercholesterolemia, Lipid Disorder
Conditions
Keywords
hyperlipidemia, cardiovascular disease, atherosclerotic cardiovascular disease
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.
Interventions
DRUGStatin (rosuvastatin 10 or 40 mg daily, depending on risk)
moderate- or high-intensity statin (either rosuvastatin 10 mg daily or rosuvastatin 40 mg daily)
BEHAVIORALHealthy Lifestyle Counseling
Healthy lifestyle counseling based off the American Heart Association's Life Essential 8 framework
OTHEROutpatient Followup
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
Sponsors
Wake Forest University Health Sciences
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
130 Emergency Department patients will be randomized with chest pain 1:1 to Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders (EMERALD) or usual care.
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Evaluation for Acute Coronary Syndrome 2. Age 40-75 Years 3. 10-year Atherosclerotic Cardiovascular Disease (ASCVD) Risk ≥7.5% or Known Diabetes or Known ASCVD: 1. Myocardial Infarction 2. Unstable Angina 3. Percutaneous Coronary Intervention 4. Coronary Artery Bypass Graft 5. Stroke 6. Transient Ischemic Attack 7. Peripheral Artery Disease
Exclusion criteria
1. ST-Segment Elevation Myocardial Infarction (STEMI) Activation 2. ST Depression \>1 mm in Contiguous Leads 3. On a Lipid Lowering Agent (Statin, PCSK9 Inhibitor, Bempedoic Acid, Ezetimibe, Inclisiran, etc.) 4. Inability to Return for 30-day Follow-up 5. Unstable Vitals (Systolic blood pressure \<90, HR \>120 or \<50, oxygen saturation \<90%) 6. Statin Intolerance 7. Any Resulted High-Sensitivity Troponin I ≥100 ng/L 8. End-stage renal disease (ESRD) and/or glomerular filtration rate (GFR) \<30 mL/min/1.73 m2 9. Liver Cirrhosis 10. Pregnancy 11. Anticipated Hospitalization 12. Life Expectancy \<1 Year 13. Transfer from Another Hospital 14. Prisoner 15. Non-English Speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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? |
| 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? |
| 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 |
Countries
United States
Contacts
CONTACTLauren Koehler
CONTACTNick Ashburn
PRINCIPAL_INVESTIGATORNick Ashburn
Nicklaus.Ashburn@wfusm.edu
Outcome results
None listed