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SUDDEN CARDIAC ARREST
A Community Presentation on the ALPS Study
PORTLAND RESUSCITATION OUTCOMES CONSORTIUM
What is this forum about?
• We want your opinion on research that
might involve you or a family member. We
are studying the use of heart rhythm
medications in cardiac arrest. This will be
done with an Exception From Informed
Consent.
What is Exception from Informed
Consent (EFIC)
• A federal regulation (21 CFR 50.24) allows
studies that meet the following rules to use this
exception:
 Patient’s lives must be at risk.
 Available treatments are not satisfactory.
 Patients are unable to give consent.
 The possible risks are reasonable.
 Being in the research study could help patients
(increased survival).
 It would not be possible to do the research
practically without this exception.
EFIC Regulations
• Collect input and opinions from the community about the
possible research.
 Tell the community about the research (public disclosure)
 Find out what people think (community consultation)
• Patients who are in this study will need immediate treatment.
Without intervention, patients in cardiac arrest will quickly
die.
• We cannot collect informed consent before starting
treatment because:
 Patients in cardiac arrest are unconscious. They don’t have a
pulse and not able to give us permission.
 Treatment must start immediately, and the next of kin may not
be present, or may be too upset to understand an the research
study.
“Opt-Out” Option
• An option for community members.
• A “No Study” bracelet will be sent to those who
ask for one by calling 503-494-8083 or email
[email protected].
Notification & Consent
• The study interventions are completed upon
patient arrival to the hospital.
• We will ask for consent from patients to review
medical records related to the current
hospitalization only.
• Taking part in this study is very brief. People will
be allowed to leave this study as soon as they
are able to say they want to stop.
Public Health Problem
• Cardiovascular disease (CVD) is the number one health threat
to most adult Americans.
• Each year, 1.25 million people experience an acute myocardial
infarction (MI) or “heart attack.”
• Approximately 300,000 to 350,000 persons die from out-ofhospital cardiac arrest (“sudden death”) each year in North
America.
 Survival rate remains poor (less than 8% nationally)
 Sudden death can happen shortly after a person start to have
heart attack symptoms
It’s important to note that a heart attack is NOT the
same thing as a cardiac arrest! Cardiac arrest can
be a devastating complication of a heart attack.
This study focuses on cardiac arrest specifically.
Heart Attack – Why call 9-1-1
• Early treatment by Emergency Medical Services (EMS)
providers*




Oxygen
Heart monitoring
Medications
Electrocardiogram (“EKG”)
• Getting patients to treatment quickly (Rapid transport to
appropriate facility).
• Treatment of problems and complications.
 Sudden cardiac arrest
 Low blood pressure, heart failure
*Local fire departments and ambulance
services staffed with EMTs and paramedics.
What is sudden cardiac arrest?
• Electrical system in the heart
malfunctions.
• Heart unexpectedly and abruptly
stops beating.
• Sometimes caused by an abnormal
heart rhythm called ventricular
fibrillation or VF.
 About one-third caused by VF.
 Remainder caused by other lethal heart
rhythms (PEA, Asystole, Bradycardia,
Tachycardia).
• Often associated with a heart attack.
• Majority occur outside of a hospital.
Ventricular Fibrillation (VF)
What VF looks like on an EKG
Shock “converts” VF to better rhythm
Defibrillation (electrical shock) is
the primary solution (cannot be
used in other lethal heart rhythms)
Importance of Early Defibrillation
% Success
100
90
Chances of success
decrease 7–10%
each minute
80
70
60
50
40
30
20
10
0
0
1
2
3
4
5
6
7
Time to Defibrillation (minutes)
8
9
American Heart Association (AHA)
“Chain of Survival”
• Communities with the following things in place
tend to have the best rates of survival:
 Understanding that emergency services are needed and
calling 9-1-1 immediately.
 Early CPR, especially with quality chest compressions
 Rapid defibrillation (an electrical shock to the heart)
 Effective paramedics (advanced life support )
 Follow up care (post-cardiac arrest care)
The “Chain of Survival”
The ALPS Trial
• ALPS: Amiodarone, Lidocaine, Placebo,
Study
• Amiodarone and Lidocaine are medications
currently used by paramedics to stabilize the
heart (referred to as heart rhythm
medications).
• Normally given if VF continues or recurs after
the first defibrillation
The ALPS Trial
• We do not know which of the two
medications is the most effective.
• Or whether they are effective at all.
• ALPS will attempt to find out which is better,
or if neither (the placebo, normal saline) is
better.
Preliminary Trials
• Two prior trials:
 Amiodarone may be better than Lidocaine, as well as no drug
therapy (placebo).
 Both studies looked at how many people were admitted to the
hospital after cardiac arrest. Neither study had enough patients
to see how many patients survived to hospital discharge.
• Both medications are currently used in our EMS system.
Both are used as one of the main treatments.
• Both medications could be harmful. We do not know how
many patients survive to hospital discharge.
 False hope
 The use of these drugs may stop people from receiving other
more effective treatments.
How will the trial work?
• EMS services will have a kit with three
syringes.
• The kit will contain either Amiodarone,
Lidocaine or saline in each of the three
syringes.
• The paramedics will not know what is
contained in the syringes.
• In cases of cardiac arrest, where VF recurs
after an initial defibrillation, they will use the
syringes in the study kit
Drug Kit Design
Three (3) identical (blinded) syringes
SYRINGE #
AMIODARONE KIT
LIDOCAINE KIT
PLACEBO KIT
1
Amiodarone 150 mg (3 cc)
Lidocaine 60 mg (3 cc)
Placebo (3 cc)
2
Amiodarone 150 mg (3 cc)
Lidocaine 60 mg (3 cc)
Placebo (3 cc)
3
Amiodarone 150 mg (3 cc)
Lidocaine 60 mg (3 cc)
Placebo (3 cc)
Why is there a placebo?
• A recent study from Norway showed that there
was NO difference in survival from cardiac
arrest when individuals were given intravenous
medications (including heart rhythm agents)
when compared to no medications outside the
hospital.
• Also, medications can have side effects that
could cause problems and actually make the
effects of cardiac arrest worse.
ALPS Study Outcome Measures
• Primary
 Survival to hospital discharge
• Secondary
 Survival to hospital discharge with good function
Potential Benefits
• Paramedics taking part in this study will
receive extra training. Patients may benefit
from this extra training (the Hawthorne effect).
• Results would change how we
treat/resuscitate patients worldwide.
Who will be included in the study?
• Patients that will be included:
 Adult patients in cardiac arrest in whom VF
recurs after the first defibrillation.
• Patients that will be excluded:
 Known pregnant women.
 Children under the age of 18 years.
 Prisoners.
 Patients wearing a “No Study” bracelet.
 Patients with Do Not Resuscitate (DNR) orders
ALPS Patient Safety Monitoring
• The study will be monitored by:
 Data Safety Monitoring Board (DSMB)—an
independent group
 Institutional Review Board (IRB)
 Food & Drug Administration (FDA)
 National Institutes of Health (NIH)
Potential Adverse Events
• Amiodarone:
 Slow heart rate, low blood pressure, vein
irritation
• Lidocaine:
 Seizures, slow heart rate, low blood pressure
• These will be watched and tracked and
reported to the FDA and DSMB
Our Ultimate Goal
To find the best treatment methods
for managing cardiac arrest, in order
to save more lives!
Questions?
Do you have any
concerns about this
proposed research
study?
For more information, visit our website at:
www.ohsu.edu/emergency/roc
Supplemental
Slides
To be used if questions about
heart attacks come up in the
discussion.
What is a heart attack?
• A heart attack is caused by the interruption of blood flow
to the heart.
• If this continues, heart muscle cells suffer injury and die.
• Depending on how much heart muscle is damaged,
disability or death can occur.
• In some cases, a heart attack can result in cardiac arrest.
• Other names for a heart attack:




Acute Myocardial Infarction (AMI)
Myocardial Infarction (MI)
Coronary Thrombosis
Coronary Occlusion
What causes a heart attack?
• Blood clot (thrombosis) that blocks one of the coronary arteries
• Usually seen with underlying Coronary Artery Disease
 Hardening and narrowing of the coronary arteries due to the
buildup of plaque (atherosclerosis) in the walls
Blocked
artery
Reduced
blood flow
Damaged area
Muscle
damage
begins
Symptoms of a Heart Attack
• Chest pain, discomfort, pressure, or squeezing
• Upper-body pain or discomfort in one or
both arms, back, shoulders, neck, jaw, or
upper part of stomach
• Shortness of breath
• Breaking out in a cold sweat
• Unusual or unexplained fatigue (tiredness),
particularly in women (may be present for days)
• Nausea/vomiting
• Light-headedness or sudden dizziness
A Heart Attack is an Emergency!
• Time is critical!
• Prompt treatment can reduce damage!
• Early intervention can prevent death!
CALL 9-1-1!
Don’t drive yourself
to the hospital!