Clinical trial NCT05742841
Conditions: Lipid Disorder
Keywords: hyperlipidemia cardiovascular disease atherosclerotic cardiovascular disease
Sponsor: Wake Forest University Health Sciences
Start date: 2023-03-08; Completion date: 2023-07-15
Enrollment: 22 participants; Allocation: NA; Intervention model: SINGLE_GROUP

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.

Arms: arm 1: 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
Interventions: intervention 1: moderate- or high-intensity statin/ rosuvastatin
Intervention descriptions: intervention 1: moderate- or high-intensity statin (either rosuvastatin 10mg daily or rosuvastatin 40 mg daily)

Protocol documents:
ICF_002.pdf: 
Official Title:EMERALD (Emergency Medicine Cardiovascular Risk Assessment for 
Lipid Disorders)
NCT05742841
IRB-Approved Date: 6/4/2023


Page 1 of 9
Adult Consent Form
IRB Template Version 3/1/2021
EMERGENCY MEDICINE - CARDIOVASCULAR RISK ASSESSMENT FOR 
LIPID DISORDERS (EMERALD)
Informed Consent Form to Participate in Research
 Simon Mahler, MD, MS, Principal Investigator
SUMMARY
You are invited to participate in a research study. The purpose of this research is to determine the 
effectiveness of patients starting medication for high lipid levels (hyperlipidemia) after visiting 
the Emergency Department. You are invited to be in this study because you have presented to the 
ED with chest pain and may have hyperlipidemia. Your participation in this research study will 
involve today’s enrollment and 1 follow-up visit. 
Participation in this study will involve running an ED lipid panel lab in the Emergency 
Department, starting the study medication, which is either a moderate- or high-intensity statin, 
and a 30-day research follow-up visit where we will recheck your lipid panel.   
All research studies involve some risks.  A risk to this study that you should be aware of is the 
risk associated with taking the study medication, statins. You may or may not benefit from 
participation in this study.  
Your participation in this study is voluntary.  You do not have to participate in this study if you 
do not want to.  There may be other choices available to you.  Some other choices may include 
receiving the standard of care treatment in the emergency department. You could also receive a 
referral for outpatient care.  You will not lose any services, benefits, or rights you would 
normally have if you chose not to participate. 
The remainder of this form contains a more complete description of this study. Please read this 
description carefully. You can ask any questions if you need help deciding whether to join the 
study. If you have questions, suggestions, or concerns regarding this study or you want to 
withdraw from the study please contact the Principal Investigator, Simon Mahler at 
.
If you have any questions, suggestions or concerns about your rights as a volunteer in this 
research, contact the Institutional Review Board at 
 or the Wake Forest University 
Health Sciences Research Subject Advocate at 
.
Department of Emergency Medicine
WFU School of Medicine 
Institutional Review Board 
IRB Number: IRB00091989
Meeting Date Approved 6/4/2023          
Version Valid Until: 2/13/2024


Page 2 of 9
Adult Consent Form
IRB Template Version 3/1/2021
INTRODUCTION
You are invited to be in a research study. Research studies help scientists learn new information 
that may help other people in the future. You are being asked to be in this study because you 
have chest pain and may have hyperlipidemia. Your participation is voluntary. You do not have 
to be a part of this study if you do not want to.  Please take your time in making your decision if 
you would like to join. Ask your study doctor or the study staff to explain any words or 
information contained in this informed consent document that you do not understand. You may 
also discuss the study with your friends and family.
WHY IS THIS STUDY BEING DONE?
This study is being done to determine the effectiveness of initiating medication for 
hyperlipidemia (HLD) in the ED. Hyperlipidemia is a key risk factor that is associated with 
heart disease, which is one of the leading causes of death in the US. However, patients are 
rarely screened for Hyperlipidemia in the ED and ED providers rarely initiate medication for 
hyperlipidemia. Thus, there is a clear opportunity to improve health for the patients who 
present to the ED with undiagnosed and/or unmanaged hyperlipidemia. 
By starting a statin, which are an already approved class of medication by the U.S Food and 
Drug Administration (FDA), patients can potentially start to manage their hyperlipidemia after 
being treated in the ED.
HOW MANY PEOPLE WILL TAKE PART IN THE STUDY?
20 subjects will take part in this study 
WHAT IS INVOLVED IN THE STUDY?
For patients enrolled, the following will occur: 
1. Your provider will order a lipid panel today in the ED, 
2. Your provider will then determine if you should be on a statin medication
3. Your provider will then prescribe a statin in the ED,
4. During the 30 days before your follow-up appointment, you will complete a drug 
diary daily.
5. You will then complete the 30-day follow-up visit to recheck your lipid panel. 
If you take part in this study, you will have the following tests and procedures: You will have 
approximately 5 teaspoons of blood withdrawn from a vein on 2 occasions to test your lipid 
panel. The total amount of blood withdrawn during the study will be approximately 10 
teaspoons. A pregnancy test may also be performed as standard of care if you are a female of 
child-bearing capacity. 
When you depart from the emergency department you will have 7 days to pick up your study 
medication, a statin which is prescribed to you by an Emergency Medicine provider. The 
prescription will be sent to the pharmacy of your choice. You can choose to complete your drug 
diary daily through Redcap surveys or on paper. A drug diary allows us to capture if you took 
WFU School of Medicine 
Institutional Review Board 
IRB Number: IRB00091989
Meeting Date Approved 6/4/2023          
Version Valid Until: 2/13/2024


Page 3 of 9
Adult Consent Form
IRB Template Version 3/1/2021
your medication daily and if you had any side effects. You will be asked to return for a 30-day 
follow-up visit to retest your lipid panel. At the 30-day follow-up, you should bring your paper 
drug diary if you chose to complete it this way. 
You will then be prescribed the study drug for up to 30-days as long as no serious side effects 
occur. If you experience any side effects please follow-up with your primary care doctor or call 
Dr. Simon Mahler at 
. You can also refill the prescription through your PCP.  If 
you do not have a PCP at the initial enrollment, we will refer you to one. 
HOW LONG WILL I BE IN THE STUDY?
You will be in the study for about 30 days.  There is 1 follow-up which occurs around the 30-day 
mark from ED enrollment. 
You can stop participating at any time. If you decide to stop participating in the study, we 
encourage you to talk to the investigators or study staff first.
WHAT ARE MY RESPONSIBILITIES IF I TAKE PART IN THIS 
RESEARCH?
If you agree to take part in this study, you must take the study treatment as instructed and do all 
study test and assessments. It is important that you follow the instructions from your study 
doctor. It is also important that you tell study staff about any other medicines, vitamins or herbal 
supplements you are taking before and during the study. You should especially tell your 
healthcare professional if you take blood thinners, medications for HIV/AIDS, and/or medication 
for preventing pregnancy as these drugs may have contraindications with the study drug.
You should also tell your health care professional before taking the study drug if you have a 
history of muscle pain or weakness, drink more than 2 glasses of alcohol daily, have liver 
problems, have kidney problems, have thyroid problems, and are Asian or of Asian descent.
 If you are female, you must not be pregnant or breast-feeding. Tell your study doctor if you are 
pregnant, are attempting to become pregnant or are breastfeeding. If the pregnancy test is 
positive you will discontinue treatment with study medication in the study. We will not retest 
you in the Emergency Department if your initial pregnancy test is positive. If you become 
pregnant during the study you should notify the study doctor right away and you should stop 
study medication. 
You should inform your study doctor or the study staff of any concerns you may have or any 
new health issues you may experience 
WHAT ARE THE RISKS OF THE STUDY?
Being in this study involves some risk to you. You should discuss the risk of being in this study 
with the study staff. You may experience no side effects, some or all of these. Risk and side 
effects of taking statins include:
WFU School of Medicine 
Institutional Review Board 
IRB Number: IRB00091989
Meeting Date Approved 6/4/2023          
Version Valid Until: 2/13/2024


Page 4 of 9
Adult Consent Form
IRB Template Version 3/1/2021

Muscle problems/muscle pains,

Headache,

Dizziness,

muscle pain,

low blood platelet count,

liver damage, 

kidney damage,

myalgia, 

abdominal pain,

asthenia,

nausea
It is also not possible to rule-out the chance of an allergic reaction to the study drug.  Some 
symptoms of allergic reactions are mild (hives, itching) while others can be life-threatening 
(difficulty breathing, swelling of the throat). If you have difficulty breathing and/or swelling of 
the throat (a life-threatening allergic reaction), call 9-1-1 and contact Dr. Mahler 
.
You may experience discomfort, bruising and/or bleeding where the needle is inserted. 
Occasionally some people become dizzy lightheaded or feel faint. Infection may occur on rare 
occasions.  Frequent donation of blood can result in low iron in your blood (iron deficient 
anemia).  
Taking part in this research study may involve providing information that you consider 
confidential or private.  Efforts, such as coding research records, keeping research records secure 
and allowing only authorized people to have access to research records, will be made to keep 
your information safe.
There also may be other risks that we cannot predict. You should tell the research staff about all 
the medications, vitamins and supplements you take and any medical conditions you have. This 
may help avoid side effects, interactions and other risks to your health.
Reproductive Risks and other Issues to Participating in Research
Due to unknown risks and potential harm to the unborn fetus, sexually active women of 
childbearing potential must use a reliable method of birth control while participating in this 
study. Reliable methods of birth control are: abstinence (not having sex), oral contraceptives, 
OrthoEvra patch, NuvaRing, intrauterine devices (IUD), Nexplanon implant, DepoProvera, tubal 
ligation, or vasectomy of the partner (with confirmed negative sperm counts) in a monogamous 
relationship (same partner). An acceptable, although less reliable, method involves the careful 
use of condoms and spermicidal foam or gel and/or a diaphragm with spermicide with Plan B 
WFU School of Medicine 
Institutional Review Board 
IRB Number: IRB00091989
Meeting Date Approved 6/4/2023          
Version Valid Until: 2/13/2024


Page 5 of 9
Adult Consent Form
IRB Template Version 3/1/2021
used for any noticed condom or diaphragm failures. We encourage you to discuss this issue 
further with your physicians if you have any questions.
Pregnant women are excluded from participation in this study. Because NO method of birth 
control is 100% reliable, a pregnancy test is required at least 10 days from your last normal 
menstrual period, if you are a sexually active woman of childbearing potential.
ARE THERE BENEFITS TO TAKING PART IN THE STUDY?
If you agree to take part in this study, there may or may not be direct benefit to you. Because 
individuals respond differently to the study medication, no one can know in advance if it will be 
helpful in your case.
Just by taking part in this research study, you may be helping future patients by providing 
important information about the standard of care provided in the emergency department by 
contributing to future medical knowledge.
WHAT OTHER CHOICES ARE THERE?
You do not have to be in this study. You should talk to the research staff about all the choices 
you have. Instead of being in this study, you have these options: Receiving standard of care in 
the emergency department, seeing an outpatient provider, being prescribed a statin if applicable 
even if you do not take part in the study. 
WHAT ARE THE COSTS?
Study costs, including the initial lipid panel, and other costs related directly to the study, will be 
paid for by the research study. The 30-day visit costs, including the 2nd lipid panel, will also be 
covered for by the study. Costs for your regular medical care and for the research study 
medication, are your own responsibility and will be charged to your insurance.
WILL YOUR RESEARCH RECORDS BE CONFIDENTIAL?
The results of this research study may be presented at scientific or medical meetings or published 
in scientific journals.  Your identity and/or your personal health information will not be disclosed 
unless it is authorized by you, required or permitted by law, or necessary to protect the safety of 
yourself or others.  
Your information may be provided to Federal and other regulatory agencies as required.  The 
Food and Drug Administration (FDA), for example, may inspect research records and learn your 
identity if this study falls within its jurisdiction.
______________________ I give permission to Atrium Health, Wake Forest University Health 
Sciences, and their respective affiliated entities and representatives (including third-party agents 
if applicable) to contact me by text message at the number I provided to send information, 
reminders, and to communicate with me about the research study. I understand that I am 
responsible for the standard text message rate of my carrier. I also understand that text messaging 
is not a secure form of communication and I accept the risk that individuals not involved in the 
WFU School of Medicine 
Institutional Review Board 
IRB Number: IRB00091989
Meeting Date Approved 6/4/2023          
Version Valid Until: 2/13/2024


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Adult Consent Form
IRB Template Version 3/1/2021
research study may be able to access the text messages.  I also understand that texting is not to be 
used for emergency situations.  
 ______________________ By providing my email address, I give permission for Atrium 
Health, Wake Forest University Health Sciences, and their respective affiliated entities and 
representatives (including third-party agents if applicable) to send me information, reminders, 
and messages about the research study by email. I understand that these email messages may not 
be encrypted, and I understand and accept the risks that individuals not involved in the research 
study may be able to access unencrypted email messages. I also understand that email is not to be 
used for emergency situations. 
WILL YOU BE PAID FOR PARTICIPATING?
You will be paid $25 if you complete the scheduled study visit. If you withdraw for any reason 
from the study before completing the 30-day visit you will not be paid.  
WHAT HAPPENS IF YOU EXPERIENCE AN INJURY OR ILLNESS AS A 
RESULT OF PARTICIPATING IN THIS STUDY?
Wake Forest University Baptist Medical Center maintains limited research insurance coverage 
for the usual and customary medical fees for reasonable and necessary treatment of injuries or 
illnesses to some participants in certain research studies. To the extent research insurance 
coverage is available under this policy, the reasonable costs of these necessary medical services 
will be paid, up to a maximum of $25,000.  To the extent research coverage is not available, you 
or your insurance company may be charged for the costs of medical care. You may receive care 
at Wake Forest University Baptist Medical Center and/or Atrium Health.
If you are injured, the insurer may require information such as your name, social security 
number, and date of birth in order to pay for your care.  This is because the insurer is required by 
law to report any payments made to cover the care of any persons who are members of a 
government insurance plan to the Department of Health and Human Services.
You do not give up any legal rights as a research participant by signing this consent form. For 
more information on medical treatment for research related injuries or to report a study related 
illness, adverse event, or injury you should call Simon Mahler at 
.
WHAT ABOUT MY HEALTH INFORMATION.
In this research study, any new information we collect from you about your health or behaviors 
is considered Protected Health Information. The information we will collect for this research 
study includes: demographics, lab values, medications, medical history, other test results and 
contact information. 
If this research study involves the diagnosis or treatment of a medical condition, then Protected 
Health Information collected from you during this study will be placed in your medical record, 
WFU School of Medicine 
Institutional Review Board 
IRB Number: IRB00091989
Meeting Date Approved 6/4/2023          
Version Valid Until: 2/13/2024


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Adult Consent Form
IRB Template Version 3/1/2021
and will be used to help treat you, arrange payment for your care, or assist with the health care 
operations of Atrium Health, Wake Forest University Health Sciences, and their respective 
affiliated entities. 
If you choose to participate in this study, your medical record at Atrium Health, Wake Forest 
University Health Sciences, or their respective affiliated entities will indicate that you are 
enrolled in a clinical trial. Information about the research and any medications or devices you are 
being given as a participant may also be included in your medical record. Authorization to access 
this part of the medical record will only be available to people who have a need to know this 
information in order to perform their job-related duties. If you are not a patient of these health 
care facilities, a medical record will be created for you anyway to provide access to this 
important information to providers in case of an emergency.
We will take steps to keep your Protected Health Information private. We will store records of 
your Protected Health Information in a cabinet in a locked office or on a password protected 
computer. 
Your personal health information and information that identifies you (“your health information”) 
may be given to others during and after the study. This is for reasons such as to carry out the 
study, to determine the results of the study, to make sure the study is being done correctly, to 
provide required reports and to get approval for new products.  
Some of the people, agencies and businesses that may receive and use your health information 
are the research sponsor; representatives of the sponsor assisting with the research; investigators 
at other sites who are assisting with the research; central laboratories, reading centers or analysis 
centers; the Institutional Review Board; representatives of Wake Forest University Health 
Sciences and Atrium Health Facilities; representatives from government agencies such as the 
Food and Drug Administration (FDA) or the Office of Human Research Protections (OHRP), the 
Department of Health and Human Services (DHHS) and similar agencies in other countries. 
Some of these people, agencies and businesses may further disclose your health information. If 
disclosed by them, your health information may no longer be covered by federal or state privacy 
regulations.  Your health information may be disclosed if required by law. Your health 
information may be used to create information that does not directly identify you. This 
information may be used by other researchers. You will not be directly identified in any 
publication or presentation that may result from this study unless there are photographs, 
videotapes, audiotapes or other recorded media which are identify you unless we you’re your 
written authorization.
If required by law or court order, we might also have to share your Protected Health Information 
with a judge, law enforcement officer, government agencies, or others. If your Protected Health 
Information is shared with any of these groups, it may no longer be protected by federal or state 
WFU School of Medicine 
Institutional Review Board 
IRB Number: IRB00091989
Meeting Date Approved 6/4/2023          
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Adult Consent Form
IRB Template Version 3/1/2021
privacy rules.
Any Protected Health Information collected from you in this study that is maintained in the 
research records will be kept for at least six years after the study is finished. At that time any 
research information not already in your medical record will either be destroyed, or it will be de-
identified You will not be able to obtain a copy of your Protected Health Information in the 
research records until all activities in the study are completely finished. 
You can tell Dr. Simon Mahler that you want to take away your permission to use and share your 
Protected Health Information at any time by sending a letter to this address:
Simon Mahler, MD
However, if you take away permission to use your Protected Health Information you will not be 
able to be in the study any longer. We will stop collecting any more information about you, but 
any information we have already collected can still be used for the purposes of the research 
study.
By signing this form you give us permission to use your Protected Health Information for this 
study.
Laboratory test results and other clinically relevant medical reports created as a result of your 
participation in the research study may be entered into the computer systems of Atrium Health, 
Wake Forest University Health Sciences, and/or their respective affiliated entities.  These results 
and reports will be kept secure in compliance with applicable laws, with permission to access 
this information limited to individuals with proper authority, but who may not be directly 
involved with this research study.
WHAT ARE MY RIGHTS AS A RESEARCH STUDY PARTICIPANT?
Taking part in this study is voluntary. You may choose not to take part or you may leave the 
study at any time. Refusing to participate or leaving the study will not result in any penalty or 
loss of benefits to which you are entitled. If you decide to stop participating in the study we 
encourage you to talk to the investigators or study staff first to learn about any potential health or 
safety consequences. The investigators also have the right to stop your participation in the study 
at any time. This could be because it is in your best medical interest, your condition worsened, 
new information becomes available, you had an unexpected reaction, you failed to follow 
instructions, or because the entire study has been stopped.  Information that identifies you may 
be removed from the data or specimens that are collected as part of this study and could be used 
for future research or shared with others without additional consent. 
WFU School of Medicine 
Institutional Review Board 
IRB Number: IRB00091989
Meeting Date Approved 6/4/2023          
Version Valid Until: 2/13/2024


Page 9 of 9
Adult Consent Form
IRB Template Version 3/1/2021
You will be given any new information we become aware of that would affect your willingness 
to continue to participate in the study.
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required 
by U.S. Law.  This website will not include information that can identify you.  At most, the 
website will include a summary of the results.  You can search this Web site at any time.
WHOM DO I CALL IF I HAVE QUESTIONS OR PROBLEMS?
For questions about the study or in the event of a research-related injury, contact the study 
investigator, Dr. Simon Mahler at 
The Institutional Review Board (IRB) is a group of people who review the research to protect 
your rights. If you have a question about your rights as a research participant, or you would like 
to discuss problems or concerns, have questions or want to offer input, or you want to obtain 
additional information, you should contact the Chairman of the IRB at 
 or the 
Research Subject Advocate at 
You will be given a copy of this signed consent form. 
SIGNATURES
I agree to take part in this study. I authorize the use and disclosure of my health information as 
described in this consent and authorization form.  If I have not already received a copy of the 
Privacy Notice, I may request one or one will be made available to me.  I have had a chance to 
ask questions about being in this study and have those questions answered.   By signing this 
consent and authorization form, I am not releasing or agreeing to release the investigator, the 
sponsor, the institution or its agents from liability for negligence.
Subject Name (Printed):_____________________________
Subject Signature: _________________________________ Date: ________Time:_______ am pm 
Person Obtaining Consent (Printed):_____________________________
Person Obtaining Consent:___________________________ Date:_________ Time:________ am pm
WFU School of Medicine 
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IRB Number: IRB00091989
Meeting Date Approved 6/4/2023          
Version Valid Until: 2/13/2024

Prot_003.pdf: 
Protocol version: 
Template updated 9.24.14 
1 
EMERALD (Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders) 
 
 
IRB00091989 
 
 
NCT05742841 
 
 
07JUN2023 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Protocol version: 
Template updated 9.24.14 
2 
Study Title: EMERALD (Emergency Medicine Cardiovascular Risk Assessment for 
Lipid Disorders 
 
Principal Investigator, Co-investigator(s):  Dr. Nicklaus Ashburn, Dr. Simon Mahler 
 
Sponsor or funding source: Atrium Health Wake Forest Baptist  
 
Background, Rationale and Context  
 
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 (future NHLBI submission). 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. 1–3 It is 
estimated that almost 40% of ED patients with chest pain have poorly managed or 
unrecognized HLD.4 However, patients are rarely screened for HLD in the ED and ED initiation 
medical therapy for HLD is exceedingly uncommon. Because HLD is rarely screened for, 
prescribing a statin is not the standard of care in the Emergency Department. Therefore, the 
current ED care paradigm, which does not address HLD, represents a missed opportunity to 
prevent ASCVD events. Every 38.7 mg/dL reduction in low-density lipoprotein-cholesterol (LDL-
C) is associated with a 21% decrease in ASCVD events and a 24% decrease in mortality. 5,6 
Thus, there is a clear opportunity to improve health for the millions of patients who present to 
the ED each year with undiagnosed and/or unmanaged HLD. 7,8 Diagnosing and managing a 
CVD risk factor such as HLD in the ED would be innovative and paradigm shifting. 
 
To address this gap in ASCVD prevention we have developed a novel ED-based HLD screening 
and treatment program: EMERALD (Emergency Medicine Cardiovascular Risk Assessment for 
Lipid Disorders). This program adapts HLD recommendations from the 2013 AHA/ACC and 
2022 US Preventive Services Task Force guidelines to the ED setting. The EMERALD 
intervention involves 1) ordering an ED lipid panel, 2) calculating 10-year ASCVD risk using the 
Pooled Cohort Equations9, 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). 10–12 Our preliminary data demonstrate that >90% of ED 
patients with acute chest pain believe the ED is an appropriate place to evaluate for HLD and 
>80% believe it is a reasonable place to start medical therapy for HLD. However, the feasibility 
of screening for HLD and initiating treatment in the ED setting is unclear.  It is unknown whether 
patients prescribed HLD treatment will fill these prescriptions, take their medication, and 
complete scheduled follow-ups. In addition, it is not clear whether busy Emergency Physicians 
will adopt and follow the steps of a preventative HLD care program. 
 
Objectives  
 
What is needed now is a pilot study examining if the ED can screen for HLD and estimate the 
anticipated effect size of EMERALD in lowering LDL-C. We propose a pilot study with 20 
patients designed to assess the feasibility of EMERALD and to explore changes in LDL-C by 
initiating medical therapy in the ED. The specific aims of this study are: 
 
Aim 1: Test the feasibility of EMERALD. We will determine the proportion of patients who 
receive a complete EMERALD assessment (ED lipid panel drawn, 10-year ASCVD risk 


Protocol version: 
Template updated 9.24.14 
3 
calculated with the Pooled Cohort Equations, and prescribed a statin), fill their prescription 
within 7-days of the ED encounter, and follow-up at 30-days for a repeat lipid panel. 
 
Aim 2: Explore changes in LDL-C after initiating preventive care with statin therapy in the 
ED. The primary outcome will be change in LDL-C at 30-days. The secondary outcome will be 
change at 30-days in non-high-density lipoprotein-cholesterol (non-HDL-C). 
 
Our experienced team is well-equipped to conduct this pilot study. This innovative proposal is a 
key step for determining if EMERALD is feasible and estimating its impact on LDL-C at 30-days. 
Our team consists of experts in emergency medicine, preventive cardiology, lipid disorders, and 
biostatistics. There is strong potential that the EMERALD concept could improve care for 
millions of ED patients across the US who have undiagnosed and/or unmanaged HLD. The 
concept could be expanded to other modifiable CVD risk factors, including diabetes, 
hypertension, obesity, and smoking. 
 
 
Methods: 
 
Overview and Design 
 
We propose a pilot study with 20 patients designed to assess the feasibility of EMERALD 
and to explore changes in LDL-C by initiating medical therapy in the ED. 
 
Subjects will be screened for Emerald in the Emergency Department. Research staff and 
investigators will screen for subjects in the Emergency Departments with the electric screening 
“track boards”. We will then screen patient health records and speak to their ED providers about 
EMERALD.  Labs will be ordered so that we can either rule in or out a patient for research.  
 
If they meet inclusion and no exclusion criteria, their treating Emergency Physician will be 
asked to initiate the EMERALD protocol, including: 1) ordering a lipid panel during the index 
ED encounter and 30-days after ED discharge, 2) completion of the Pooled Cohort 
Equations, and 3) starting medical therapy (moderate- or high-intensity statin, if appropriate) 
in the ED. 
 
The research will take place in the Emergency Department at Wake Forest Baptist Medical 
Center. Follow-ups will occur in the CTSI CRU space, Emergency Medicine CRU, or, if deemed 
appropriate, at an alternate site (e.g., subject's residence, local healthcare professional's site) 
for the 30 day follow-ups.  
     
 
Subjects selection criteria 
Treatments for Hyperlipidemia in ED settings: 
 
 
Inclusion Criteria 
• 
ED patients with chest pain 
• 
40-75 years old 
• 
An LDL-C ≥70 mg/dL on an ED lipid panel or have known diabetes or ASCVD 
• 
Negative standard of care pregnancy test or documented inability to bear children 
for female participants 
 


Protocol version: 
Template updated 9.24.14 
4 
 
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 (BP <90, HR >120 or <50, O2 sat <90%) 
• 
Statin Intolerance 
• 
High-sensitivity Troponin I ≥100 ng/L 
• 
ESRD and/or GFR <30 mL/min/1.73 m2 
• 
Liver Cirrhosis 
• 
Hospitalization 
• 
Life Expectancy <1 Year 
• 
Transfer from Another Hospital 
• 
Prisoner 
• 
Non-English Speaking 
 
 
 
Intervention and Procedure  
 
This program adapts HLD recommendations from the 2013 AHA/ACC and 2022 US 
Preventive Services Task Force guidelines to the ED setting.  
 
To close this critical evidence gap, we propose a pilot study, which will test the feasibility of 
EMERALD and explore changes in LDL-C concentrations using 20 ED patients with chest 
pain who are 40-75 years old with an LDL-C ≥70 mg/dL on an ED lipid panel or have known 
diabetes or ASCVD. For patients enrolled, their treating Emergency Physician will be asked 
to initiate the EMERALD protocol, including: 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, 3) starting medical 
therapy (moderate- or high-intensity statin/ rosuvastin) in the ED, if applicable, and 4) having 
subjects complete a drug diary documenting drug usage. This pilot will provide critical data 
regarding the feasibility of the EMERALD intervention and its estimated effect size on LDL-C 
concentration, which are needed to inform a future randomized trial (future NHLBI 
submission). Ignition funds will be used to pay for lipid measures, support statistical 
analysis, and provide patient compensation. This pilot project is essential for providing 
preliminary data for a future randomized controlled trial of EMERALD (future NHLBI 
submission). 
 
 
The EMERALD procedure involves  
1) Ordering an ED lipid panel 
2) The subject’s ED provider calculating the 10-year ASCVD risk using the Pooled 
Cohort Equations9 at the index visit, 
3) Based on the trial diagram, prescribing a moderate- or high-intensity statin (either 
rosuvastatin 10mg daily or rosuvastatin 40 mg daily) if applicable,  


Protocol version: 
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5 
4) Have subjects complete a drug diary during the 30 days before their follow-up, and  
5) Bring subjects back 30-days (+/- 5 business days) after ED discharge to retest their 
Lipid Panel 
 
Outcome 
 
This pilot study will provide preliminary data regarding the feasibility of EMERALD and estimate 
its impact on LDL-C and non-HDL-C. We anticipate the pilot data will demonstrate that 
implementation of EMERALD is feasible in an ED setting (ED lipid panel drawn, 10-year ASCVD 
risk assessment performed, and statin therapy initiated) and will result in a trend towards 
reduced LDL-C among participants. 
 
 
Analytical Plan 
This pilot study will provide preliminary data regarding the feasibility of EMERALD and estimate 
its impact on LDL-C and non-HDL-C. We anticipate the pilot data will demonstrate that 
implementation of EMERALD is feasible in an ED setting (ED lipid panel drawn, 10-year ASCVD 
risk assessment performed, and statin therapy initiated) and will result in a trend towards 
reduced LDL-C among participants. These data will support a future NHLBI submission (likely 
K23 award for Dr. Nicklaus Ashburn with Dr. Mahler as mentor), which will use a randomized 
controlled trial design to examine the efficacy and patient adherence to EMERALD on a larger 
scale. If the pilot data are not supportive of the EMERALD concept, then the investigative team 
will reconsider the EMERALD program design before pursuing NIH funding. In either case, the 
data from this pilot will be essential for future proposals and used to produce the first publication 
regarding ED-initiated medical therapy for HLD. 
 
Human Subjects Protection 
 
General requirements: The study will be conducted in compliance to this study protocol, the 
current version of the Declaration of Helsinki, ICH GCP, and applicable local legal and 
regulatory requirements. 
 
Submission of study documents: Before study start, the study protocol, and subject information / 
informed consent and any other study-related document as required by applicable laws and 
regulations will be submitted to the Ethics Committee and regulatory authorities for written 
approval. Any protocol amendments or new or amended information that requires ethical 
consideration will be submitted for written approval, too. In addition, a study report (interim and 
/or full report) will be submitted to regulatory authorities in line with applicable timelines. 
 
Subject information and informed consent: Participation in this study will include a written 
informed consent, which will be collected in the ED. All subjects or legal representatives will be 
informed orally and in writing about the objectives of the study, its procedures, potential risks, 
and about the fact that to some extent data will be accessible for third parties - provided that 
data confidentiality is ensured at any time. The participation in this study will be entirely 
voluntary. Subjects will have the right to withdraw their willingness to participate in the trial at 
any time without affecting their future medical care in any way. Informed consent will be 
obtained from both the investigators and from the study coordinators  
 
Clinical study results and publication:  The results of the clinical study will be documented in a 
clinical study report and will be published (e.g. in a journal or presented in a scientific meeting). 
 


Protocol version: 
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6 
Data confidentiality: Auditors, Ethics Committee, and the regulatory authorities will be granted 
direct access to the subject’s medical records to the extent permitted by the applicable law and 
regulation for verification of clinical study procedures, and/or data control, ensuring subject data 
confidentiality. The subject’s file and the source data will be archived in line with national and 
international legal requirements. 
 
Data and Safety Monitoring 
The principal investigator will be responsible for the overall monitoring of the data and safety of 
study participants.  The principal investigator will be assisted by other members of the study 
staff. 
 
Reporting of Unanticipated Problems, Adverse Events or Deviations 
Any unanticipated problems, serious and unexpected adverse events, deviations or protocol 
changes will be promptly reported by the principal investigator or designated member of the 
research team to the IRB and sponsor or appropriate government agency if appropriate. 
 
 
 
References 
 
1.  Ference BA, Ginsberg HN, Graham I, et al. Low-density lipoproteins cause atherosclerotic 
cardiovascular disease. 1. Evidence from genetic, epidemiologic, and clinical studies. A 
consensus statement from the European Atherosclerosis Society Consensus Panel. Eur 
Heart J. 2017;38(32):2459-2472. 
2.  Virani SS, Alonso A, Aparicio HJ, et al. Heart Disease and Stroke Statistics-2021 Update: A 
Report From the American Heart Association. Circulation. 2021;143(8):e254-e743. 
3.  Vassy JL, Lu B, Ho YL, et al. Estimation of Atherosclerotic Cardiovascular Disease Risk 
Among Patients in the Veterans Affairs Health Care System. JAMA Netw Open. 
2020;3(7):e208236. 
4.  Blomkalns AL, O’Connell EM, Eady CE, Lindsell CJ, Gibler WB. Evaluation of dyslipidemia 
in the emergency department: impact of cholesterol testing on subsequent therapy. Am 
Heart J. 2006;152(6):1182-1186. 
5.  Cholesterol Treatment Trialists’ (CTT) Collaboration, Baigent C, Blackwell L, et al. Efficacy 
and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 
170,000 participants in 26 randomised trials. Lancet. 2010;376(9753):1670-1681. 
6.  Ross SD, Allen IE, Connelly JE, et al. Clinical outcomes in statin treatment trials: a meta-
analysis. Arch Intern Med. 1999;159(15):1793-1802. 
7.  Owens PL, Barrett ML, Gibson TB, Andrews RM, Weinick RM, Mutter RL. Emergency 
department care in the United States: a profile of national data sources. Ann Emerg Med. 
2010;56(2):150-165. 
8.  Hooker EA, Mallow PJ, Oglesby MM. Characteristics and Trends of Emergency 
Department Visits in the United States (2010-2014). J Emerg Med. 2019;56(3):344-351. 


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9.  Goff DC Jr, Lloyd-Jones DM, Bennett G, et al. 2013 ACC/AHA guideline on the assessment 
of cardiovascular risk: a report of the American College of Cardiology/American Heart 
Association Task Force on Practice Guidelines. Circulation. 2014;129(25 Suppl 2):S49-73. 
10.  Gulati Martha, Levy Phillip D., Mukherjee Debabrata, et al. 2021 
AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR Guideline for the Evaluation and Diagnosis of 
Chest Pain. J Am Coll Cardiol. 2021;78(22):e187-e285. 
11.  Whelton Paul K., Carey Robert M., Aronow Wilbert S., et al. 2017 
ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the 
Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults. J 
Am Coll Cardiol. 2018;71(19):e127-e248. 
12.  US Preventive Services Task Force, Mangione CM, Barry MJ, et al. Statin Use for the 
Primary Prevention of Cardiovascular Disease in Adults: US Preventive Services Task 
Force Recommendation Statement. JAMA. 2022;328(8):746-753. 
 
Appendix 
1. Data collection form 
2. Copies of each questionnaires or surveys that will be used 
3. Consent form if one will be used 
4. Other Appendix items as appropriate