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NCT06488105PHASE2Recruiting

Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders Trial

Wake Forest University Health Sciences

Start Date

8/5/2024

Completion Date

3/31/2029

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.

Eligibility Criteria

Age Range: 40 years to 75 years

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

Interventions

DRUG

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

BEHAVIORAL

Healthy Lifestyle Counseling

OTHER

Outpatient Followup

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Conditions

Lipid DisorderHypercholesterolemiaCardiovascular DiseasesAtherosclerosis

Locations

Wake Forest University Health Sciences

Winston-Salem, North Carolina 27517

United States