ACCESS Trial

PUBLIC NOTIFICATION OF COMPLETION OF THE ACCESS CLINICAL TRIAL

ACCESS (ACCESS TO THE CARDIAC CATHETERIZATION LABORATORY IN PATIENTS WITHOUT ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION RESUSCITATED FROM OUT-OF-HOSPITAL VENTRICULAR FIBRILLATION CARDIAC ARREST) HAS BEEN COMPLETED IN [NAME] COUNTY.

About the Research

The purpose of the ACCESS trial was to determine which of two standard treatments, if any, results in better outcome: (1) Initial cardiac catheterization laboratory (CCL) admission, or (2) initial intensive care unit (ICU) admission in adults 18-80 years of age successfully resuscitated from out-of-hospital cardiac arrest and no signs of a heart attack on tracings of the heartbeat.

This study was performed at 26 research sites throughout the United States and Canada where Michigan Medicine participated but did not enroll any patients. Patients were included in the study following informed consent with the patient, their next-of-kin, or using exception from informed consent under emergency circumstances if the patient was unable to speak and next-of-kin could not be found. A total of 65 patients were entered into the ACCESS trial between January, 2018 and July, 2019; 68% were male with an average age of 64 years. Of the 65 patients, 75% were Caucasian, 15% were African-American, 8% were of unknown race, 1.6% were Native American, 1.6% were Asian, 3% of patients were Hispanic, and 23% were of unknown ethnicity.

Study Results

The ACCESS trial was stopped early, in July, 2019, because the rate of subject enrollment was too low. The study results showed no difference in patient outcomes between treatment with initial CCL admission compared to initial ICU admission, including survival and functionally favorable survival at hospital discharge and 3 months following hospital discharge.

For additional information, please contact the study team at 734-615-4626 or by email to [email protected]

LEARN ABOUT ACCESS: AN EMERGENCY CARDIAC ARREST STUDY THAT MAY AFFECT YOU OR SOMEONE YOU KNOW

ACCESS is a research study 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.

What is Ventricular Fibrillation (V-FIB)

V-fib occurs if disorganized electrical signals make the heart ventricles quiver instead of pump normally. Without the ventricles pumping blood to the body, such as during V-fib, sudden cardiac arrest and death can occur within a few minutes

EKGS and Myocardial Infarctions

An Electrocardiogram (EKG or ECG) shows the electrical function of the heart. The heart pumps blood to the body because electricity in the heart muscles causes the heart to contract. Doctors can use EKGs to tell how much of the heart muscle wall is damaged during a Myocardial Infarction (or Heart Attack). EKG tracings showing ST-Elevation Myocardial Infarction (STEMI) heart attacks tell doctors that an artery in the heart is blocked.

It becomes harder to decide what to do next when the EKG does not show a STEMI or Non-ST-elevation myocardial infarction. In those cases, doctors may suspect, but can’t be sure whether there is a blockage in the artery.

Who will be included?

• 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 VT or VF (Ventricular Tachycardia)
• No ST-segment elevation MI on ED 12- lead EKG as interpreted by a physician

Why participate in this study?

Some experts believe patients with No-STEMI (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 catheterization lab in some cases.

What are the risks and benefits?

Because we do not know which treatment is best for people with these types of heart attacks, a person enrolled in the study may receive a better treatment method.  Based on the information we get from this study, people who have No-STEMI after a VT/VF in the future may benefit from what is learned in this study.

Risks common to both treatments are infection, damage to the liver, damage to the heart with low blood pressure, damage to multiple organs in the body, seizures, repeated cardiac arrest, survival to hospital discharge with decreased function, and death.  Risks associated with catheterization are heart attack (caused by the catheterization), stroke (caused by the catheterization), injury to the catheterized artery, tear in the heart or heart artery, fluid or blood around the heart, bleeding requiring blood transfusion, kidney damage (caused by contrast dye), and death (as a direct complication of catheterization). The risks of these complications generally occur less than 1 out of 100 times.

How is ACCESS different than other studies?

Due to the short treatment window, we will have to act within the first 45 minutes following ED arrival.  We will try to get in-person contact with a legally authorized representative and have a formal informed consent discussion.

If that is not possible, we will try telephone contact with patient representatives to ask about general objections to enrollment in any research. If there is no family contact within the first 45 minutes; the patient will be treated in the trial under EFIC.

What is EFIC?

The U.S. Department of Health and Human Services (DHHS) is a federal agency that oversees human research protection. The FDA and DHHS have created a set of special rules, called “Waiver/ Exception from Informed Consent” (EFIC). These special rules allow research studies in certain emergency situations to be conducted without consent.  Before researchers may do a study using EFIC, they must provide information about the study to the community and get their feedback.

How can I share my opinion?

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. There will also be information about the study in the media.

How can I be excluded from the study?

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 Study Declined” to it. If you have a medic alert membership you can add “ACCESS Study 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. Call 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 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 resuscitated cardiac arrest patients at the hospital in your community.