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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23HL169929-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders (EMERALD) arm | Experimental | In 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. |
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| Usual Care Arm | Active Comparator | Patients 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Index ED encounter through 30 days (-3, +11 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in LDL-C at 180 days. | Percent change in LDL-C from the index ED encounter through 180 days | Index ED encounter through 180 days (+/- 15 days) |
| Percent change in non high-density lipoprotein cholesterol (non-HDL-C) at 30 days |
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Inclusion Criteria
Known ASCVD:
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lauren Koehler | Contact | 336-716-4646 | Lauren.Koehler@Advocatehealth.org | |
| Nick Ashburn | Contact | Nicklaus.Ashburn@wfusm.edu |
| Name | Affiliation | Role |
|---|---|---|
| Nick Ashburn | Nicklaus.Ashburn@wfusm.edu | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Recruiting | Winston-Salem | North Carolina | 27517 | United States |
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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.
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| Healthy Lifestyle Counseling | Behavioral | Healthy lifestyle counseling based off the American Heart Association's Life Essential 8 framework |
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| 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 |
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Percent change in non-HDL-C from the index ED encounter through 30 days
| Index ED encounter through 30 days (-3, +11 days) |
| Percent change in non-HDL-C at 180 days | Percent change in non-HDL-C from the index ED encounter through 180 days | Index ED encounter through 180 days (+/- 15 days) |
| Proportion of patients with outpatient clinic follow-up at 30 days | Did the patient follow-up with the recommended outpatient care team? | Index ED encounter through 30 days (-3, +8 days) |
| Proportion of patients with statin prescription pick-up | Did the patient pick-up their statin prescription from the pharmacy? | Index ED encounter through 10 days |
| Qualitative barriers and facilators | Qualitative interviews to determine facilitators and barriers to the Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders (EMERALD) program | 30 days (+30 days) after the index ED encounter |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D006937 | Hypercholesterolemia |
| D002318 | Cardiovascular Diseases |
| D050197 | Atherosclerosis |
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D050171 | Dyslipidemias |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D019161 | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D000924 | Anticholesteremic Agents |
| D000960 | Hypolipidemic Agents |
| D000963 | Antimetabolites |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D004791 | Enzyme Inhibitors |
| D057847 | Lipid Regulating Agents |
| D045506 | Therapeutic Uses |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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