A Phase 2 interventional study of Statin (rosuvastatin 10 or 40 mg daily, depending on risk) and Healthy Lifestyle Counseling in Lipid Disorder, Hypercholesterolemia and Cardiovascular Diseases, sponsored by Wake Forest University Health Sciences. Recruiting at 1 site in United States. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-02-27.
Sponsored by Wake Forest University Health Sciences · Phase 2, Interventional, and Prevention
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.
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.
1,175 studies on the registry are indexed under Hypercholesterolemia; 93 are open to participants now.
This study's planned enrollment of 130 is above the median of 110 across 975 interventional studies indexed under Hypercholesterolemia.
Browse Hypercholesterolemia studies →Wake Forest University Health Sciences is the lead sponsor of 1,351 studies on the registry; 201 are open to participants now.
Of its 332 completed or terminated interventional studies of FDA-regulated products, 251 (76%) have results posted.
Compared within Hypercholesterolemia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Lipid Metabolism Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Known ASCVD:
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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/dL 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 \<20% or those with known diabetes and 10-year risk \<20%) who will receive a moderate-intensity statin (rosuvastatin 10 mg daily) and a primary care referral. EMERALD patients will also receive healthy lifestyle counseling.
Drug: Statin (rosuvastatin 10 or 40 mg daily, depending on risk) · Behavioral: Healthy Lifestyle Counseling · Other: Outpatient Followup
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.
Behavioral: Healthy Lifestyle Counseling · Other: Outpatient Followup
moderate- or high-intensity statin (either rosuvastatin 10 mg daily or rosuvastatin 40 mg daily)
Also known as: Crestor
Healthy lifestyle counseling based off the American Heart Association's Life Essential 8 framework
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
Percent change in low-density lipoprotein cholesterol (LDL-C) at 30 days
Percent change in LDL-C from the index Emergency Department (ED) encounter through 30 days
Time frame: Index ED encounter through 30 days (-3, +11 days)
Percent change in LDL-C at 180 days.
Percent change in LDL-C from the index ED encounter through 180 days
Time frame: Index ED encounter through 180 days (+/- 15 days)
Percent change in non high-density lipoprotein cholesterol (non-HDL-C) at 30 days
Percent change in non-HDL-C from the index ED encounter through 30 days
Time frame: Index ED encounter through 30 days (-3, +11 days)
Percent change in non-HDL-C at 180 days
Percent change in non-HDL-C from the index ED encounter through 180 days
Time frame: Index ED encounter through 180 days (+/- 15 days)
Proportion of patients with outpatient clinic follow-up at 30 days
Did the patient follow-up with the recommended outpatient care team?
Time frame: Index ED encounter through 30 days (-3, +8 days)
Proportion of patients with statin prescription pick-up
Did the patient pick-up their statin prescription from the pharmacy?
Time frame: Index ED encounter through 10 days
Qualitative barriers and facilators
Qualitative interviews to determine facilitators and barriers to the Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders (EMERALD) program
Time frame: 30 days (+30 days) after the index ED encounter
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2024 (actual). Primary completion is estimated for Nov 2027, 39 months after the start.
Of 48 phase 2 interventional studies under Hypercholesterolemia, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 18. This study's planned 39 months is above that.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Statins
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