[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100553593":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":39,"centralContacts":44,"locations":51,"responsibleParty":67,"collaborators":69,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":77,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":34,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":98,"overallStatus":53,"whyStopped":34,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Wake Forest University Health Sciences","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders (EMERALD) arm","EXPERIMENTAL","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\u002FdL 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 \\\u003C20% or those with known diabetes and 10-year risk \\\u003C20%) who will receive a moderate-intensity statin (rosuvastatin 10 mg daily) and a primary care referral. EMERALD patients will also receive healthy lifestyle counseling.",[13,14,15],"Drug: Statin (rosuvastatin 10 or 40 mg daily, depending on risk)","Behavioral: Healthy Lifestyle Counseling","Other: Outpatient Followup",{"label":17,"type":18,"description":19,"interventionNames":20},"Usual Care Arm","ACTIVE_COMPARATOR","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.",[14,15],[22,29,35],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"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)",[9],[28],"Crestor",{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"BEHAVIORAL","Healthy Lifestyle Counseling","Healthy lifestyle counseling based off the American Heart Association's Life Essential 8 framework",[9,17],null,{"type":6,"name":36,"description":37,"armGroupLabels":38,"otherNames":34},"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",[9,17],[40],{"name":41,"affiliation":42,"role":43},"Nick Ashburn","Nicklaus.Ashburn@wfusm.edu","PRINCIPAL_INVESTIGATOR",[45,50],{"name":46,"role":47,"phone":48,"phoneExt":34,"email":49},"Lauren Koehler","CONTACT","336-716-4646","Lauren.Koehler@Advocatehealth.org",{"name":41,"role":47,"phone":34,"phoneExt":34,"email":42},[52],{"facility":5,"status":53,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"RECRUITING","Winston-Salem","North Carolina","27517","United States","US",{"type":60,"coordinates":61},"Point",[62,63],-80.24422,36.09986,{"lat":63,"lon":62},[66],{"name":46,"role":47,"phone":34,"phoneExt":34,"email":34},{"type":68,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR",[70,73],{"name":71,"class":72},"National Institutes of Health (NIH)","NIH",{"name":74,"class":72},"National Heart, Lung, and Blood Institute (NHLBI)","100553593","phase-2-emergency-medicine-cardiovascular-risk-assessment-for-lipid-disorders-trial-100553593",false,"NCT06488105","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","EMERALD RCT","Inclusion Criteria\n\n1. Evaluation for Acute Coronary Syndrome\n2. Age 40-75 Years\n3. 10-year Atherosclerotic Cardiovascular Disease (ASCVD) Risk ≥7.5% or Known Diabetes or\n\nKnown ASCVD:\n\n1. Myocardial Infarction\n2. Unstable Angina\n3. Percutaneous Coronary Intervention\n4. Coronary Artery Bypass Graft\n5. Stroke\n6. Transient Ischemic Attack\n7. Peripheral Artery Disease\n\nExclusion Criteria\n\n1. ST-Segment Elevation Myocardial Infarction (STEMI) Activation\n2. ST Depression \\>1 mm in Contiguous Leads\n3. On a Lipid Lowering Agent (Statin, PCSK9 Inhibitor, Bempedoic Acid, Ezetimibe, Inclisiran, etc.)\n4. Inability to Return for 30-day Follow-up\n5. Unstable Vitals (Systolic blood pressure \\\u003C90, HR \\>120 or \\\u003C50, oxygen saturation \\\u003C90%)\n6. Statin Intolerance\n7. Any Resulted High-Sensitivity Troponin I ≥100 ng\u002FL\n8. End-stage renal disease (ESRD) and\u002For glomerular filtration rate (GFR) \\\u003C30 mL\u002Fmin\u002F1.73 m2\n9. Liver Cirrhosis\n10. Pregnancy\n11. Anticipated Hospitalization\n12. Life Expectancy \\\u003C1 Year\n13. Transfer from Another Hospital\n14. Prisoner\n15. Non-English Speaking","ALL","40 Years","75 Years",{"count":87,"type":88},130,"ESTIMATED","INTERVENTIONAL",[91],"PHASE2","Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders (EMERALD) is a protocolized intervention based on American College of Cardiology\u002FAmerican 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.",[94,95,96,97],"Lipid Disorder","Hypercholesterolemia","Cardiovascular Diseases","Atherosclerosis",[99,100,101],"hyperlipidemia","cardiovascular disease","atherosclerotic cardiovascular disease","2026-02-26",{"date":104,"type":105},"2026-02-27","ACTUAL",{"date":107,"type":105},"2024-08-05",{"date":109,"type":88},"2029-03-31",{"name":5,"class":6},1]