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Lipid DisorderPhase 2EMERALD RCTNCT06488105

Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders Trial

A Phase 2 study testing Statin (rosuvastatin 10 or 40 mg daily, depending on risk), Healthy Lifestyle Counseling and Outpatient Followup in people with Lipid Disorder and Hypercholesterolemia, run by Wake Forest University Health Sciences at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 40 to 75 years
What is being tested?
Statin (rosuvastatin 10 or 40 mg daily, depending on risk), Healthy Lifestyle Counseling and Outpatient Followup
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
1 siteUnited States
Study dates
5 Aug 2024to 31 Mar 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • Percutaneous Coronary Intervention
  • Coronary Artery Bypass Graft
  • Stroke
  • Transient Ischemic Attack
  • Peripheral Artery Disease

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Lauren Koehler contact

336-716-4646

Lauren.Koehler@Advocatehealth.org

Nick Ashburn contact

Nicklaus.Ashburn@wfusm.edu

United States1 site, 1 recruiting

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27517

    Lauren Koehler

    Recruiting

Other trials in United States

About this study

Official title: Initiating Preventive Care for Hyperlipidemia in the Emergency Department: The EMERALD (Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders) Trial

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.

Read the 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.

Being tested
Statin (rosuvastatin 10 or 40 mg daily, depending on risk), Healthy Lifestyle Counseling, Outpatient Followup
Keywords
hyperlipidemia, cardiovascular disease, atherosclerotic cardiovascular disease
Medical subject headings
Lipid Metabolism Disorders, Hypercholesterolemia, Cardiovascular Diseases, Atherosclerosis, Hyperlipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called Crestor

    moderate- or high-intensity statin (either rosuvastatin 10 mg daily or rosuvastatin 40 mg daily)

  • Healthy Lifestyle CounselingBehavioural

    Healthy lifestyle counseling based off the American Heart Association's Life Essential 8 framework

  • Outpatient FollowupOther

    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

Study groups in NCT06488105
Study groupRoleWhat they receive
Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders (EMERALD) armExperimentalIn 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.
Receives: Drug: Statin (rosuvastatin 10 or 40 mg daily, depending on risk); Behavioral: Healthy Lifestyle Counseling; Other: Outpatient Followup
Usual Care ArmActive comparatorPatients 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.
Receives: Behavioral: Healthy Lifestyle Counseling; Other: Outpatient Followup

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Index ED encounter through 30 days (-3, +11 days)

Secondary outcomes (6)

  1. Percent change in LDL-C at 180 days.

    Percent change in LDL-C from the index ED encounter through 180 days

    Measured: Index ED encounter through 180 days (+/- 15 days)

  2. 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

    Measured: Index ED encounter through 30 days (-3, +11 days)

  3. Percent change in non-HDL-C at 180 days

    Percent change in non-HDL-C from the index ED encounter through 180 days

    Measured: Index ED encounter through 180 days (+/- 15 days)

  4. Proportion of patients with outpatient clinic follow-up at 30 days

    Did the patient follow-up with the recommended outpatient care team?

    Measured: Index ED encounter through 30 days (-3, +8 days)

  5. Proportion of patients with statin prescription pick-up

    Did the patient pick-up their statin prescription from the pharmacy?

    Measured: Index ED encounter through 10 days

  6. Qualitative barriers and facilators

    Qualitative interviews to determine facilitators and barriers to the Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders (EMERALD) program

    Measured: 30 days (+30 days) after the index ED encounter

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2024
  2. Study start5 Aug 2024
  3. Primary completion30 Nov 2027 (estimated)
  4. Study completion31 Mar 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
130 Emergency Department patients will be randomized with chest pain 1:1 to Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders (EMERALD) or usual care.
Masking
None (open label)
Enrolment
130 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06488105
Sponsor's protocol ID
IRB00104057
Other IDs
1K23HL169929-01A1
Acronym
EMERALD RCT
Status last verified
Feb 2026
First submitted
28 Jun 2024
Last updated
27 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Statin (rosuvastatin 10 or 40 mg daily, depending on risk), Healthy Lifestyle Counseling and Outpatient Followup in people with Lipid Disorder and Hypercholesterolemia, run by Wake Forest University Health Sciences at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lauren Koehler (336-716-4646, Lauren.Koehler@Advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent change in low-density lipoprotein cholesterol (LDL-C) at 30 days (time frame: Index ED encounter through 30 days (-3, +11 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06488105.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.

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