- What is the ACCESS Clinical Trial?
- Participation in the ACCESS Trial
- ACCESS Trial Background
- Cardiac Arrest Awareness
What is the ACCESS Clinical Trial?
Sudden Cardiac Arrest occurring outside of the hospital setting is the third leading cause of death in the United States. It is an immediate electrical malfunction (arrhythmia) of the heart. This event disrupts heart pumping, which in turn stops blood flow to the rest of the body.
Eighty percent of survivors suffer cardiac arrest due to arrhythmias known as Ventricular Tachycardia (VT) or Ventricular fibrillation (VF).
VT/VF cardiac arrests have the highest survival rate and greatest opportunity for improvement in treatment and outcome for this devastating public health problem.
ACCESS is an NHLBI funded multi-center research study that aims to determine the best method of care for survival and neurological recovery for patients resuscitated after cardiac arrest due to ventricular fibrillation (VF) outside of the hospital, but who have no evidence of a heart attack on electrocardiogram (ECG). Participating sites shown below.
Why is it important to study VF arrest without evidence of heart attack on ECG?
Of the estimated 120-130,000 VT/VF arrests each year, 70% of these cases do not show a heart attack on ECG.
Previous research has shown that this group may be likely tohave a clot in their heart arteries but not have signs of a clot on their ECG (acute coronary occlusion). Other patients that show signs of a clot on their ECG, are immediately taken to the cardiac catheterization laboratory (cath lab or CCL) in order to have an invasive procedure (called “catheterization”) to remove the clot and restore blood flow to their heart.
Despite this current research, a wide variation of clinical practice exists in the United States, varying from hospital to hospital.
A preliminary pilot has shown the benefits of early access to the cath lab for patients with VT/VF arrests.
The ACCESS Trial will be the first randomized clinical trial (of this nature) to provide reliable data on which clinical practice can be based and consistently provided. It will study two standard care approaches to the treatment of resuscitated VF cardiac arrest patients:
Standard treatment option 1: Initial transport to the cath lab
Standard treatment option 2: Initial transport to the Intensive Care Unit (ICU) for consultation by a cardiologist who will then make a decision whether or not to transport to the cath lab
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 initial cath lab admission, results in significantly improved functionally favorable survival compared with current practices.
For more information on understanding clinical trials:
Sources: See ACCESS Trial Background
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 or
- 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's family to ask if the patient is known to have any objections to enrollment in any research.
- If they are unable to reach the patient's LAR 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.
- Adults presumed or known to be 18-75 years old
- Resuscitated from out-of-hospital-cardiac-arrest, (have a heart beat in the Emergency Department [ED])
- Initial cardiac arrest rhythm of pulseless VF or VT (Ventricular Fibrillation/VentricularTachycardia)
- No ST-segment elevation myocardial infarction (N-STEMI) on ED 12-lead EKG as interpreted by a physician
How can I learn more about participation in the ACCESS trial?
Sites across the U.S. are in various stages of ACCESS trial community awareness. If you have questions about your state or community, contact email@example.com . Minnesota has completed the community consultations/focus groups and currently are notifying the public we are enrolling for the trial. Public notification releases in a variety of languages are available below and will be continuous throughout the trial.
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 firstname.lastname@example.org .
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.
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.
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.
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.
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.
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
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.