Clinical trial on cardiac arrest won’t require patient consent

INDIANAPOLIS, Ind. – Researchers at the IU Medical School want to inform the public about an upcoming clinical trial that will not require the consent of patients suffering from cardiac arrest.

Starting in early September, cardiac arrest patients taken to Eskenazi and Methodist hospitals will be randomly selected for treatment in a specialized catheterization lab instead of the intensive care unit.

“This trial asks the question of whether that will help some people survive when their heart stops beating,” said Dr. Jeffrey Kline, Vice Chair of Research for the Department of Emergency Medicine at the IU Medical School. “This is a trial to understand how to improve survival in patients that have sustained sudden death.”

Kline says the premise of the study is that many patients who have a heart attack, or blockage of an artery that feeds blood to the heart, never go into cardiac arrest, or sudden stoppage of the heart. But about half of cardiac arrest patients suffer heart stoppage because of a heart attack.

“Many patients who have sudden death had a heart attack and we can’t see it with the EKG or any blood testing at the bedside,” Kline said. “So we have to take them to the cardiac cath lab to find that out.”

The ACCESS trial is exempt from requiring informed consent from patients, meaning unconscious patients may be redirected to a catheterization lab without giving doctors permission if a family member or legal representative isn’t available to give consent.

A conscious patient can opt out of the trial by simply telling medics and doctors they don’t want to be a part of it. Those patients will be given a green bracelet.

“The paramedics will immediately know that the patient will not go into the study and they will get usual care at the discretion of the doctors and nurses,” Kline said.

But if a cardiac arrest patient is not able to speak, and no one is there to speak for them, they have a 50-50 chance of being taken to the catheterization lab even if no heart blockage is detected.

The trial at Eskenazi and Methodist hospitals is part of a national trial taking place at other hospitals around the country. It’s expected to start in the first week of September and could last two years. Dr. Kline says there have been several public information sessions held in an effort to inform the community about the upcoming trial.

You can read more about the ACCESS trial on the IU Medical School’s website.