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NCT Number: NCT06488105

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.

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Key information

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27517, United States

Location status: Recruiting

Location contact

Lauren Koehler

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

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

Other names: Crestor

Healthy Lifestyle Counseling

Behavioral

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

Outpatient Followup

Other

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

Primary outcomes

  1. Percent change in low-density lipoprotein cholesterol (LDL-C) at 30 days

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

    Percent change in LDL-C from the index Emergency Department (ED) encounter through 30 days

Secondary outcomes

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

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

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

  2. Percent change in non high-density lipoprotein cholesterol (non-HDL-C) at 30 days

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

    Percent change in non-HDL-C from the index ED encounter through 30 days

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

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

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

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

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

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

  5. Proportion of patients with statin prescription pick-up

    Time frame: Index ED encounter through 10 days

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

  6. Qualitative barriers and facilators

    Time frame: 30 days (+30 days) after the index ED encounter

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

Study contacts

Contact information is provided by the study sponsor or research team.

Lauren Koehler

CONTACT

[email protected]

336-716-4646

Nick Ashburn

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Institutes of Health (NIH)

Registry information

Official study title

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

Acronym: EMERALD RCT

Important dates

Study start
2024
Primary completion
2027
Study completion
2029
First posted
Jul 5, 2024
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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