Cardiovascular risk assessment for patients with lipid disorders in emergency care
Initiating Preventive Care for Hyperlipidemia in the Emergency Department: The EMERALD (Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders) Trial
PHASE2 · Wake Forest University Health Sciences · NCT06488105
This study is testing a new way to help emergency room patients with high cholesterol lower their heart disease risk by providing better care compared to the usual treatment.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 40 Years to 75 Years |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences (other) |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Trial ID | NCT06488105 on ClinicalTrials.gov |
What this trial studies
The Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders (EMERALD) aims to improve preventive cardiovascular care for emergency department patients evaluated for acute coronary syndrome. This intervention includes ordering a lipid panel, calculating atherosclerotic cardiovascular disease risk, prescribing statins, providing lifestyle counseling, and ensuring follow-up care. The study will compare the effectiveness of this protocolized approach against usual care in reducing LDL cholesterol levels among at-risk patients. A total of 130 patients will be randomized to either the EMERALD intervention or standard care to assess outcomes at 30 and 180 days.
Who should consider this trial
Good fit: Ideal candidates are adults aged 40-75 who are being evaluated for acute coronary syndrome and have a 10-year ASCVD risk of 7.5% or higher.
Not a fit: Patients with ST-segment elevation myocardial infarction, unstable vitals, or those already on lipid-lowering agents may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly lower cholesterol levels and improve cardiovascular health in emergency department patients.
How similar studies have performed: Previous studies have shown promise in similar interventions aimed at improving cardiovascular care in emergency settings, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Winston-Salem, North Carolina
- Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States (RECRUITING)
Study contacts
- Principal investigator: Nick Ashburn — Nicklaus.Ashburn@wfusm.edu
- Study coordinator: Lauren Koehler
- Email: Lauren.Koehler@Advocatehealth.org
- Phone: 336-716-4646
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lipid Disorder, Hypercholesterolemia, Cardiovascular Diseases, Atherosclerosis, hyperlipidemia, cardiovascular disease, atherosclerotic cardiovascular disease