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What is the ACCESS Clinical Trial?

“Clinical trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective for humans. These studies also may show which medical approaches work best for certain illnesses or groups of people.”

Clinical trials are the final step in a long process that help direct health care decision making.  Prior to the clinical trial, extensive laboratory studies have been conducted and ideas tested.  This ensures that the concept is promising and the next step is a clinical trial to test risks, benefits and potential long-term outcomes.   

What is the ACCESS trial and why is it important?
Almost 92 percent of Americans who suffer from sudden cardiac arrest outside of hospitals die within minutes and in the past 30 years, the average national survival rate has not increased. ACCESS is a research trial that aims to determine the best method of care for patients resuscitated after an out-of-hospital ventricular fibrillation (V-fib) cardiac arrest, but who have no EKG evidence of a heart attack. 

  • 395,000 out-of-hospital cardiac arrests occur each year in the US with an overall survival rate of about 6%.
  • 80% of all survivors have specific type of arrest called ventricular tachycardia or ventricular fibrillation (VT/VF).  These specific types of arrest are being targeted in this trial for a new treatment to improve outcomes.
  • Patients with VT/VF likely to have a reversible cause called an acute coronary occlusion or severe coronary ischemia (inadequate blood supply to the heart).
  • 70% do not have an indication called a ST-segment elevation on 12-lead ECG performed in the pre-hospital (ambulance) setting and emergency department. 45% of these patients have been shown to have one of the treatable conditions listed above by emergent cardiac cathererization laboratory (cath lab) intervention.
  • Despite this, current treatment of VT/VF patients with no ST-segment elevation is dependent on the center.  
  • A preliminary pilot has shown the benefits of early access to the cath lab for patients with VT/VF arrests.    

How is this trial different?
Because cardiac arrest is a life-threatening situation, this trial has been developed using a statistical approach that allows the early success of the pilot to design the trial; and as it proceeds, new data will be considered for ongoing patient care.  The primary goal is to ensure that more patients will receive what the trial is showing, as the best model, for patient outcomes. 

What do we hope to show from this study?

  • That VT/VF cardiac arrest is a strong predictor of an underlying and correctable cardiac condition.
  • That changing the standard of care to initial cath lab admission, results in significantly improved functionally favorable survival compared with the current standard of care, initial intensive care unit (ICU) admission.

Participation in the ACCESS Trial

What is different about emergency clinical research?
Participation in clinical trials is voluntary and individuals are given information prior to agreeing to take part in a clinical trial.  However, emergency clinical research is different.   When serious medical conditions result in an unconscious patient, that patient cannot give informed consent or refusal to participate in a trial.  In specific and rare situations, clinical trials are allowed to enroll and treat patients as part of a research trial using an exception from informed consent for emergency research (EFIC). 

What is EFIC?
The U.S. department of Health and Human Services (DHHS) is a federal agency that oversees human research protection. The DHHS has created a set of special rules, called “Waiver/ Exception from Informed Consent” (EFIC). These special rules allow research trials in certain emergency situations to be conducted without consent.

EFIC can only be used when:

  • The person’s life is at risk, AND,
  • The best treatment is not known, AND
  • The study might help the person, AND
  • It is not possible to get permission:
    • from the person because of his or her medical condition nor
    • from the person’s guardian because there is a very short amount of time required to treat the medical problem

Before researchers may do a trial using EFIC, they must provide information about the trial to the community and get their feedback.

Trials, such as ACCESS, that involve life-threatening situations with a possibility for direct benefit to participants, can utilize EFIC when consent is not possible. Because of the short treatment window, providers need to act within the first 45 minutes following emergency department arrival.

  • Study Coordinators will try to get in-person contact with a legally authorized representative (LAR) and have a formal informed consent discussion.
  • If that is not possible, they will try telephone contact with patient representatives to ask about general objections to enrollment in any research.
  • If they are unable to reachfamily within the first 45 minutes; the patient will be treated in the trial under EFIC.
  • The patient and/or their LAR will always be informed as soon as possible after the treatment has been started. 

Who would be included?
This trial is specifically for treatment of out-of-hospital cardiac arrest.  Patients will only be enrolled based on the emergent situation of cardiac arrest and identified through the resuscitation process.  If 911 is called in this type of emergency, there is the potential for enrollment. 

How can I learn more about participation in the ACCESS trial?
Before the trial starts, meetings will be held in the community to provide information, answer questions and get community members' thoughts and feelings about the study. You can participate in focus groups, call the study team to complete a one-on-one interview about the trial, or learn more from media releases in the newspaper, TV, and radio. To join a focus group or learn about community events contact dyaccess@umn.edu.

What if I don’t want to participate?
There are two methods for opting out:

1. Through a Medic Alert™ membership. If you have an existing medic alert tag or bracelet you can add “ACCESS Trial Declined” to it. If you have a medic alert membership you can add “ACCESS Trial declined” to your Emergency Medical Information Record.  If you would like to find out more information about your existing medic alert services or for a new membership visit: www.medicalert.org

2.  Contact us to request an Opt Out bracelet be sent to you to wear with the words “ACCESS declined”.  You will need to wear this bracelet at all times during the trial period (approx.5 years), or else you could be enrolled. Email name and address to dyaccess@umn.edu .

If you do not participate in the trial, you will receive the standard medical treatment provided for resuscitated cardiac arrest patients at the hospital in your community.

ACCESS Trial Background

EKGs and non-STEMIs
It becomes harder to decide what to do next when the EKG does not show a STEMI. In those cases, doctors may suspect, but can’t be sure whether there is a blockage in the artery.

Why do this trial?
Some experts believe patients with NSTEMIs (maybe up to 30%) may have a blockage of some sort. If so, immediate cardiac catheterization may be helpful in restoring heart activity. Other experts prefer to stabilize the patients in the Intensive Care Unit (ICU) and then decide later if the patient should go to the cath lab.

Background
Past studies have shown the STEMI patients who are brought to the cath lab have a higher survival rate and are more likely to return to normal lives.

Resuscitation 2004;63:49-53 
Resuscitation 2007;72:379-385  

Other studies have suggested that the time it takes to bring these patients to the cath lab is very important.  And they have also shown that both STEMI and NSTEMI have better survival rates when they have early access to the cath lab.

https://www.ncbi.nlm.nih.gov/pubmed/22100026
https://www.ncbi.nlm.nih.gov/pubmed/20484098

The Minnesota Resuscitation Consortium, observational data was reviewed and found that early cath lab access improved survival and neurologic outcomes. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4859384/

These past studies are encouraging, but they have not changed clinical practice.  A randomized trial is needed to change how these patients are cared for. 

Results
This 5-year trial is scheduled to begin the end of 2017.  As patients are enrolled and trial results are available, they will be shared on this site.  

Resources

LIfe After SCA                                            lifeaftersca.org                                  

Sudden Cardiac Arrest Foundation            sca-aware.org

Sudden Cardiac Arrest Association            suddencardiacarrest.org

Parent Heart Watch                                   parentheartwatch.org 

MN SCA Survivors Network                        mnscasurvivor.org

Mended Hearts                                          mendedhearts.org

Ask the ICD                                               asktheicd.com

MN Resuscitation Consortium                    mrc.umn.edu and learnCPRnow.org

HeartRescue Project                                  heartrescueproject.org

Hands Only CPR                                        handsonlycpr.org

American Heart Association                      heart.org

National Heart, Lung, and Blood Institute   nhlbi.nih.gov

 

Cardiac Arrest Awareness

Sudden Cardiac Arrest (SCA) is an electrical malfunction of the heart that is immediate, and unexpected. This loss of heart function disrupts its pumping,  which in turns stops blood flow to the rest of your body.

SCA is NOT a heart attack. A heart attack is when a blockage in the arteries supplying the heart limits blood flow to a portion of the heart. A heart attack can however trigger an electrical malfunction that leads to sudden cardiac arrest.

If not treated immediately, SCA can cause sudden cardiac death. Beginning cardiopulmonary resuscitation (CPR) or chest compressions can improve the chances of survival until emergency personnel arrive.