Lipid Disorder
Conditions
Keywords
hyperlipidemia, cardiovascular disease, atherosclerotic cardiovascular disease
Brief summary
The EMERALD intervention involves 1) ordering an Emergency Department (ED) lipid panel, 2) calculating 10-year Atherosclerotic cardiovascular disease (ASCVD) risk using the Pooled Cohort Equations, 3) prescribing a moderate- or high-intensity statin if applicable, and 4) referring patients to outpatient care (primary care, preventive cardiology, or general cardiology, depending on risk level).
Detailed description
EMERALD (Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders) is a pilot study seeking to determine the feasibility of initiating medical therapy for hyperlipidemia (HLD) in the Emergency Department (ED) and will collect data essential to inform a future randomized controlled trial comparing ED HLD treatment to usual care. HLD is a key cardiovascular disease (CVD) risk factor that is causally associated with atherosclerotic cardiovascular disease (ASCVD), the leading cause of US mortality and morbidity.
Interventions
DRUGmoderate- or high-intensity statin/ rosuvastatin
moderate- or high-intensity statin (either rosuvastatin 10mg daily or rosuvastatin 40 mg daily)
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
20 patients designed to assess the feasibility of Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders (EMERALD) and to explore changes in low-density lipoprotein-cholesterol (LDL-C) by initiating medical therapy in the ED
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Emergency Department (ED) patients with chest pain * 40-75 years old * a low-density lipoprotein cholesterol (LDL-C) ≥70 mg/dL on an ED lipid panel or have known diabetes or Atherosclerotic Cardiovascular Disease (ASCVD)
Exclusion criteria
* Subject unwilling to take study medication * Pregnancy or breastfeeding * Inability to take study medication or, in the opinion of the Investigators/subject's doctors unsuitable for study participation * ST-Segment Elevation Myocardial Infarction (STEMI) Activation * ST-Segment Depression \>1 mm * On a Lipid Lowering Agent (Statin, PCSK9 Inhibitor, Bempedoic Acid, Ezetimibe, Inclisiran) * Unstable Vitals (Blood Pressure (BP) \<90, Heart Rate (HR) \>120 or \<50, O2 sat \<90%) * Statin Intolerance * 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 * Hospitalization * Life Expectancy \<1 Year * Transfer from Another Hospital * Prisoner * Non-English Speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Low-density Lipoprotein Cholesterol (LDL-C) Levels at Baseline and Day 30 | Baseline and Day 30 | A lipid panel is a common blood test that healthcare providers use to monitor and screen for risk of cardiovascular disease. The panel includes three measurements of your cholesterol levels and a measurement of your triglycerides. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| EMERALD Protocol 1\) ordering a lipid panel during the index ED encounter and 30-days (+/- 5 business days) after ED discharge, 2) completion of the Pooled Cohort Equations by the patient's ED provider at the index visit, and 3) starting medical therapy (moderate- or high-intensity statin/ rosuvastatin) in the ED
moderate- or high-intensity statin/ rosuvastatin: moderate- or high-intensity statin (either rosuvastatin 10mg daily or rosuvastatin 40 mg daily) | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | EMERALD Protocol |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants |
| Age, Continuous | 53.5 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Region of Enrollment United States | 20 Participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Low-density Lipoprotein Cholesterol (LDL-C) Levels at Baseline and Day 30
A lipid panel is a common blood test that healthcare providers use to monitor and screen for risk of cardiovascular disease. The panel includes three measurements of your cholesterol levels and a measurement of your triglycerides.
Time frame: Baseline and Day 30
Population: only participants that qualified for study drug were analyzed - 16, not all 20 Participants
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| EMERALD Protocol | Low-density Lipoprotein Cholesterol (LDL-C) Levels at Baseline and Day 30 | Baseline LDL-C | 110 mg/dL |
| EMERALD Protocol | Low-density Lipoprotein Cholesterol (LDL-C) Levels at Baseline and Day 30 | Day 30 LDL-C | 84.0 mg/dL |