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Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders Trial

ConditionsLipid DisorderHypercholesterolemiaCardiovascular DiseasesAtherosclerosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40-75
SponsorWake Forest University Health Sciences

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Evaluation for Acute Coronary Syndrome

Age 40-75 Years

10-year Atherosclerotic Cardiovascular Disease (ASCVD) Risk ≥7.5% or Known Diabetes or

Myocardial Infarction

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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)

  • Healthy Lifestyle Counseling

    Behavioral

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

  • Outpatient Followup

    Other intervention

    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

Treatment groups

130 Participants
are divided into 2 treatment groups
Group A: Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders (EMERALD) armExperimental treatment 3 interventions
Group B: Usual Care ArmActive comparator 2 interventions

Trial outcomes

Primary outcomes

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

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

Secondary outcomes

1

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)
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

Time frame
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

Time frame
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?

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wake Forest University Health Sciences

Lead sponsor

National Institutes of Health (NIH)

Collaborator

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov
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