Status:
RECRUITING
Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders Trial
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Lipid Disorder
Hypercholesterolemia
Eligibility:
All Genders
40-75 years
Phase:
PHASE2
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 Serv...
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 health...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Evaluation for Acute Coronary Syndrome
- Age 40-75 Years
- 10-year Atherosclerotic Cardiovascular Disease (ASCVD) Risk ≥7.5% or Known Diabetes or
- Known ASCVD:
- Myocardial Infarction
- Unstable Angina
- Percutaneous Coronary Intervention
- Coronary Artery Bypass Graft
- Stroke
- Transient Ischemic Attack
- Peripheral Artery Disease
- Exclusion Criteria
- ST-Segment Elevation Myocardial Infarction (STEMI) Activation
- ST Depression \>1 mm in Contiguous Leads
- On a Lipid Lowering Agent (Statin, PCSK9 Inhibitor, Bempedoic Acid, Ezetimibe, Inclisiran, etc.)
- Inability to Return for 30-day Follow-up
- Unstable Vitals (Systolic blood pressure \<90, HR \>120 or \<50, oxygen saturation \<90%)
- Statin Intolerance
- Any Resulted High-Sensitivity Troponin I ≥100 ng/L
- End-stage renal disease (ESRD) and/or glomerular filtration rate (GFR) \<30 mL/min/1.73 m2
- Liver Cirrhosis
- Pregnancy
- Anticipated Hospitalization
- Life Expectancy \<1 Year
- Transfer from Another Hospital
- Prisoner
- Non-English Speaking
Exclusion
Key Trial Info
Start Date :
August 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2029
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT06488105
Start Date
August 5 2024
End Date
March 31 2029
Last Update
May 16 2025
Active Locations (1)
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1
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27517