Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27517, United States
Location status: Recruiting
Location contact
Lauren Koehler
CONTACT
NCT Number: NCT06488105
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.
Interested in participating?
Request Info40 year–75 year
All sexes
Interventional
Phase 2
Winston-Salem, North Carolina, 27517, United States
Location status: Recruiting
Lauren Koehler
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Known ASCVD:
Exclusion criteria
moderate- or high-intensity statin (either rosuvastatin 10 mg daily or rosuvastatin 40 mg daily)
Other names: 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
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
Time frame: Index ED encounter through 180 days (+/- 15 days)
Percent change in LDL-C from the index ED encounter through 180 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
Time frame: Index ED encounter through 180 days (+/- 15 days)
Percent change in non-HDL-C from the index ED encounter through 180 days
Time frame: Index ED encounter through 30 days (-3, +8 days)
Did the patient follow-up with the recommended outpatient care team?
Time frame: Index ED encounter through 10 days
Did the patient pick-up their statin prescription from the pharmacy?
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
Contact information is provided by the study sponsor or research team.
Wake Forest University Health Sciences
Other
Initiating Preventive Care for Hyperlipidemia in the Emergency Department: The EMERALD (Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders) Trial
Acronym: EMERALD RCT
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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