PORTLAND RESUSCITATION OUTCOMES CONSORTIUM

SUDDEN CARDIAC ARRESTA Community Presentation on the ALPS Study

• 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 this forum about?

• 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.

What is Exception from Informed Consent (EFIC)

• 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.

EFIC Regulations

• 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 roc@ohsu.edu.

“Opt-Out” Option

• 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.

Notification & Consent

• 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-of-hospital 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

 

Public Health Problem

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.

• 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

Heart Attack – Why call 9-1-1

*Local fire departments and ambulance services staffed with EMTs and paramedics.

• 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.

What is sudden cardiac arrest?

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

100

90

80

70

60

50

40

30

20

10

0

% Success

1 2 3

Time to Defibrillation (minutes)

5 6 7 8 940

Chances of success decrease 7–10%

each minute

• 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)

American Heart Association (AHA) “Chain of Survival”

The “Chain of Survival”

• 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.

The ALPS Trial

• 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.

Preliminary Trials

• 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

How will the trial work?

Drug Kit DesignDrug 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)

• 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.

Why is there a placebo?

• Primary Survival to hospital discharge

• Secondary Survival to hospital discharge with good function

ALPS Study Outcome Measures

• 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.

Potential Benefits

• 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

Who will be included in the study?

• 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)

ALPS Patient Safety Monitoring

• 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

Potential Adverse Events

To find the best treatment methodsfor managing cardiac arrest, in orderto save more lives!

Our Ultimate Goal

Questions?

For more information, visit our website at:

www.ohsu.edu/emergency/roc

Do you have any concerns about this proposed research study?

Supplemental Slides

To be used if questions about heart attacks come up in the

discussion.

• 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 is a heart attack?

What causes a heart attack?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

Damaged area

Blocked artery

Reduced blood flow

Muscle damage begins

• Chest pain, discomfort, pressure, or squeezing

• Upper-body pain or discomfort in one orboth arms, back, shoulders, neck, jaw, orupper 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

Symptoms of a Heart Attack

A Heart Attack is an Emergency!

CALL 9-1-1!

• Time is critical!

• Prompt treatment can reduce damage!

• Early intervention can prevent death!

Don’t drive yourself to the hospital!