Clinical trial NCT06488105: Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders Trial
Official title: Initiating Preventive Care for Hyperlipidemia in the Emergency Department: The EMERALD (Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders) Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Lipid Disorder
Hypercholesterolemia
Cardiovascular Diseases
Atherosclerosis
Keywords: hyperlipidemia
cardiovascular disease
atherosclerotic cardiovascular disease
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2024-07-05
Enrollment: 130
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

Brief 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 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.

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.

Eligibility 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

Primary outcomes:
measure: Percent change in low-density lipoprotein cholesterol (LDL-C) at 30 days
timeFrame: Index ED encounter through 30 days (-3, +11 days)
Secondary outcomes:
measure: Percent change in LDL-C at 180 days.
timeFrame: Index ED encounter through 180 days (+/- 15 days)
measure: Percent change in non high-density lipoprotein cholesterol (non-HDL-C) at 30 days
timeFrame: Index ED encounter through 30 days (-3, +11 days)
measure: Percent change in non-HDL-C at 180 days
timeFrame: Index ED encounter through 180 days (+/- 15 days)
measure: Proportion of patients with outpatient clinic follow-up at 30 days
timeFrame: Index ED encounter through 30 days (-3, +8 days)
measure: Proportion of patients with statin prescription pick-up
timeFrame: Index ED encounter through 10 days
measure: Qualitative barriers and facilators
timeFrame: 30 days (+30 days) after the index ED encounter
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: n.ashburn@wakehealth.edu
name: Nick Ashburn
role: PRINCIPAL_INVESTIGATOR
References: