Access to the cardiac catheterization laboratory in patients without ST-segment elevation myocardial infarction resuscitated from out-of-hospital ventricular fibrillation cardiac arrest (ACCESS)
Researchers at the Medical College of Wisconsin are studying the best way to care for adults who have been successfully treated from out-of-hospital cardiac arrest.
This message is a public notice of a research study of adults successfully treated from out-of-hospital cardiac arrest, which is when a person’s heart stops beating. The study will compare two standard hospital treatments for a person after successful treatment from out-of-hospital ventricular fibrillation cardiac arrest (an irregular heart rhythm that does not pump blood). The goal of this research is to help more people live and reduce brain damage after cardiac arrest. The study will begin February, 2018 in Milwaukee County, Wisconsin.
What happens during cardiac arrest?
Cardiac arrest means that a person’s heart stops beating. When this happens, blood does not reach important organs like the brain, lungs, or kidneys. This can injure these organs. Typically, emergency services start cardiopulmonary resuscitation (CPR) until the heartbeat is normal again. When the heartbeat is normal again, people are then taken to the hospital for further treatment. In the hospital, a person will either first go for a heart procedure or first go to the intensive care unit (ICU).
Why do we need to do this research?
Right now, researchers are not sure whether a person would be helped by a heart procedure (cardiac catheterization) or not. Adults with a known blockage in the artery of their heart quickly have a heart procedure (cardiac catheterization) to remove the blockage and restore blood flow to their heart. There is no good test in adults successfully treated from out-of-hospital ventricular fibrillation cardiac arrest and a normal ECG (heart wave test) to decide who is having a blockage and who is not. About half of people do have a blockage and about half do not. Right now, people with a normal ECG may or may not have the heart procedure. It is unknown which standard of care is better. This research study is comparing whether having the heart procedure or not is better for people with a normal ECG. People in this study will be randomly chosen to have one of these two standards of care. All people will receive one of these two standards of care for cardiac arrest. The researchers will find out if more people live or have less brain damage if they first receive the heart procedure or first go the ICU.
Are there risks to this research?
All research contains potential risks. Anyone who has cardiac arrest and needs CPR has risks if they are in this study or not. The risks from cardiac arrest include damage to the brain, heart, or multiple organs, infections, seizures, another cardiac arrest, and death. Potential risks of the heart procedure (cardiac catheterization), include heart attack, stroke, injury to the artery used in the procedure, tear in the heart or heart artery, fluid or blood around the heart, bleeding requiring blood transfusion, kidney damage, and death. Less than 1 in 100 people having the heart procedure have one of these risks. There is a risk that a person having the heart procedure may not have a blockage in the heart arteries. There is also a risk if a person does not first go to have the heart procedure and they needed it. All people in both groups will receive one of these two standards of care. Every precaution will be taken to assure safety.
All information obtained from this study will remain private and confidential. The findings from this study will be presented at meetings and published in scientific journals to be useful to others. Information that could identify a person will not be used.
What is the benefit of this research?
This study may help people in the study and other people in the future. There is potential that one of the standard treatments will increase a person’s chance of living or reduce brain damage, but that benefit is not guaranteed. There are other benefits to both groups in the study. The potential benefits from a person first getting the heart procedure is potentially less heart damage or knowing that there is no blockage of the heart arteries. The potential benefits from not getting the procedure and first going to the ICU include stabilizing a person’s breathing, blood pressure, and body temperature before having the heart procedure, if needed, at a later time.
Adults treated at Froedtert Hospital may be in this study.
Cardiac arrest is an emergency and the hospital staff have to act quickly to treat a person. Researchers will attempt to get informed consent when possible. However, there may be situations where there is no time to get permission. People with cardiac arrest are usually unconscious and cannot agree to join. In studies like this, a person’s consent may not be possible. This is called an exception from informed consent under emergency circumstances. That means, if you do not want to be in this study, you must request that you not be included. You will be given a bracelet or necklace to wear that tells the hospital staff that you are not part of the study. You will still get standard treatment. The Office for Human Research Protections within the Department of Health and Human Services requires that researchers notify communities in cases when consent is not possible due to an emergency (Title 45, Section 46). Researchers will also let you know when the study is done.
Please contact us if you have questions about the risks and benefits of this study, exception from informed consent under emergency circumstances, or to get opt-out jewelry if you do not want to be in this study.
If you have questions or concerns about this study or you do not want to be in the study, contact Dr. Tom P. Aufderheide, either by phone (414) 805-6493, mail (Department of Emergency Medicine, 9200 W. Wisconsin Ave., Froedtert Hospital East, PV1, Milwaukee, WI 53226, or email (RRC@mcw.edu). If you do not want to participate, you will receive jewelry (such as a bracelet or necklace) to wear for the hospital staff to know. If you have concerns, your feedback may be used to change the study.