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RECRUITINGPhase 2INTERVENTIONAL

Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders Trial

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Statin (rosuvastatin 10 or 40 mg daily, depending on risk)

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

BEHAVIORAL

Healthy Lifestyle Counseling

Healthy lifestyle counseling based off the American Heart Association's Life Essential 8 framework

OTHER

Outpatient 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

Locations (1)

Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States