ARREST is a research study that aims to determine the best method of care for patients with a shockable rhythm who respond poorly or not at all to CPR and medications after an out of hospital cardiac arrest.
NHLBI funded, Phase II, single center (Under the Center for Resuscitation Medicine at the University of Minnesota Medical School), partially blinded, prospective, intention to treat, safety and efficacy clinical trial, randomizing adult patients (18-75 years old) with refractory ventricular fibrillation/pulseless ventricular tachycardia (VF/VT) out-of hospital cardiac arrest (OHCA) who are transferred by emergency medical services (EMS) with ongoing mechanical cardiopulmonary resuscitation (CPR) or who are resuscitated to receive one of the 2 local standards of care practiced in our community: 1) Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation or 2) Standard Advanced Cardiac Life Support (ACLS) Resuscitation
- Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation: ECMO is initiated expeditiously, regardless of whether return of spontaneous circulation (ROSC) has been achieved and with on-going mechanical CPR, if required, followed by coronary angiography and percutaneous coronary intervention (PCI) when appropriate.
- Standard Advanced Cardiac Life Support (ACLS) Resuscitation: Patients with refractory VF/VT OHCA will be treated with ACLS resuscitation for at least 15 minutes after arrival in the emergency department (ED), or up to 60 minutes from 911 call, after which the physician (MD) can continue resuscitation efforts until ROSC is achieved or futility has been reached based on their clinical judgment. If the patient has not achieved ROSC during the times mentioned above, the ED MD can declare death when he or she believes that ACLS is futile. If ROSC is present upon arrival or has been achieved anytime during resuscitation in the ED, the patient will be taken to the cardiac catheterization laboratory (CCL) for coronary angiography and PCI and potential VA ECMO or other circulatory support device initiation, as clinically indicated.
- Primary Outcome
- Survival to hospital discharge
- Survival to hospital discharge with modified Rankin Scale Score (mRS) ≤ 3 along with functional status (Cerebral Performance Category [CPC])
- Treatment cost: Cost per patient and cost per live saved
- Cardiac Arrest Awareness
More than 350,000 people in the United States die from out-of-hospital cardiac arrest (OHCA) each year. Although survival rates are higher in OHCA patients with a shockable rhythm, i.e., ventricular fibrillation/pulseless ventricular tachycardia (VF/VT; 21-35%) compared with those with a nonshockable rhythm (1-8%), more than 50% of patients with VF/VT OHCA are refractory to current treatment and never achieve return of spontaneous circulation (ROSC), or die before they are admitted to the hospital. Acute or chronic coronary artery disease (CAD) is present in 70-84% of patients with refractory VF/VT cardiac arrest, and we believe that it is the burden of significant CAD that limits the ability of conventional CPR to successfully resuscitate these patients. Coronary stenosis or occlusion can now be potentially reversed by advanced perfusion/reperfusion strategies. Thus, although patients with refractory VF/VT represent the subgroup with the worst prognosis (85-90% mortality), the underlying cause of cardiac arrest is likely to be reversible in most of these patients. It is this subgroup that offers the greatest opportunity to impact survival and public health.
Survival rates vary widely by area and population. However, despite improvements in recent years, overall survival to hospital discharge for OHCA remains under 12% even in the best EMS systems.
The research study has been reviewed by the University of Minnesota Institutional Review Board (IRB).
IRB study number: STUDY00005086
ARREST is a clinical research trial comparing 2 currently used treatments for people who have had an out-of-hospital cardiac arrest (OHCA) and arrive in the Emergency Department needing ONGOING mechanical cardiopulmonary resuscitation (CPR).
How are Out of Hospital Cardiac Arrests treated in our community?
Currently, people who have an out of hospital cardiac arrest (OHCA) with shockable rhythms (electrical activity in the heart) and arrive in the emergency department receive one of 2 standards of care at hospitals in our area: Advanced Cardiac Life Support (ACLS) with Extracorporeal Membrane Oxygenation (ECMO) if ACLS does not work OR Early ECMO facilitated Resuscitation.
What is ACLS?
Patients with shockable rhythms who respond poorly or do not achieve return of circulation after CPR will be treated with mechanical CPR and medications to attempt to get the heart pumping on its own. Sometimes, these patients may go to the cardiac cath lab for further treatment if the treating physician thinks the patient has a chance to live.
What is ECMO?
ECMO is a temporary “heart-lung bypass machine” gives the blood oxygen and circulates the blood if the heart and lungs cannot do the work. These patients will go to the cardiac cath lab for initiation of further treatment.
Why do this study?
Some evidence suggests that early access to ECMO for patients whose heart is still not pumping shows improved survival rates and improved outcomes for patients who survive. However, there is limited data on this treatment and more research needs to be conducted comparing early access to ECMO and standard ACLS (with the option of later ECMO treatments).
Who will be included?
- Adults presumed or known to be 18-75 years old
- Initial out of hospital cardiac arrest with a shockable rhythm
- No return of spontaneous circulation after 3 defibrillator shocks
- Estimated transfer time from scene to ED or Cardiac cath lab <30 minutes
What are the benefits?
The potential benefit of the research to the enrolled subjects is an improved chance of survival. Using early ECMO assisted resuscitation has shown some increased rates of survival in a small number of patients.
What are the risks?
Patients who do not respond to CPR and medications have a grim prognosis. Studies show that patients that do not get a pulse back after 15 min of CPR have a greater than 90% chance of death. Prolonged CPR causes injuries such as pneumothorax, rib fractures, solid organ injuries, and neurological issues as well as other system complications. Risks associated with ECMO and CPR include mechanical failure, hemorrhagic, neurologic, renal, cardiovascular, pulmonary, metabolic, infections, and ischemic complications.
How is enrollment in ARREST different from other studies?
Normally, researchers get permission before a person can be included in a study. A person who has a cardiac arrest needing ongoing CPR will not be able to give consent. Since a cardiac arrest that does not respond to CPR must be treated quickly, there will not be enough time to locate and talk to the person’s legal representative about the study. Data shows every 10-15 min of ongoing CPR decreases survival by 25%. Therefore all patients will be enrolled in the study without his/her legal representative’s consent. This is called “Exception from Informed Consent” (EFIC). Once the representative is located or the patient wakes up, they will be told about the study and asked to give their permission to continue in the study.
What is EFIC?
The U.S. Food and Drug Administration (FDA) is an agency of the federal government that oversees human research protection involving medicines. The FDA has created a set of special rules, called "Exception from Informed Consent" (EFIC). These special rules allow research studies in certain emergency situations to be conducted without consent. EFIC can only be used when:
- The person's life is at risk, AND
- The treatments we have don't work well, 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 form the person's representative because there is a very short amount of time required to treat the medical problem.
How can I share my opinions about this study?
Before the study 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 call the study team to complete a one-on-one interview about the study or take the survey (link below). There will also be information about the study in the media (newspapers, TV and radio).
What if I do not want to be included in the study?
Call or email us to request an Opt-Out bracelet be sent to you to wear with the words “ARREST declined”. You will need to wear this bracelet at all times during the study period (approx.5 years), or else you could be enrolled.
If you do not participate in the study, you will receive the standard medical treatment provided for cardiac arrest patients at the hospital in your community.
Where can I learn more about the study?
University of Minnesota
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 turn 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.