What is the PEARL Study?
The PEARL Study is a research study being done at Maine Medical Center in Portland, Maine with people who are brought to the emergency department in cardiac arrest. It will look at the safety and benefits of heart catheterization (heart cath) done within 90 minutes of hospital arrival in a certain group of patients that don’t have certain findings on their ECGs. This study aims to answer the question: Does an early heart catheterization improve survival in this group of patients?
What is cardiac arrest?
Cardiac arrest is when the heart suddenly stops pumping blood. In adults, this may be the result of a heart attack. It is a major public health problem because survival rates are poor. Only 4 out of 10 people who have an out-of-hospital cardiac arrest make it to the hospital alive.
Who can take part in this study?
Patients who are brought to Maine Medical Center in cardiac arrest due to heart disease but do not have certain findings on their ECG test can take part in the study. Patients who are chosen for the study will be randomly assigned to either Group 1 or Group 2.
Both groups will be treated with the standard post-arrest treatment. This includes cooling of the body which can protect the brain from injury caused by cardiac arrest.
- Group 1 will have heart catheterization right away.
- Group 2 will have standard medical treatment which may include heart catheterization. The medical team will decide if this is best for the patient.
How will you get informed consent?
To be involved in a research study the Federal Drug Administration, or FDA, requires patients to give informed consent. Informed consent means that the patient understands the risk and benefits of taking part in the study and then chooses to be part of the study.
Patients who arrive in the emergency department during cardiac arrest are not able to give informed consent because they are unconscious. A family member or legal representative may give consent for the patient. If they cannot be reached, patients can still take part in the study under what is called an Exception from Informed Consent for Emergency Research. In this case, the patient’s medical team can decide if the patient should be in the research study.
What if I do not want to be part of this study?
We will send you a bracelet to wear so that we know you do not want to take part. To get a bracelet or more information about this study please contact us at (207)-662-2066 or PEARL@mmc.org.
Questions or concerns?
You can also contact the Maine Medical Center Institutional Review Board at (207) 396-8268 or firstname.lastname@example.org.
Dr. David Seder
“The PEARL Study will tell us when cardiac catheterization should be done after a cardiac arrest and CPR. This is a crucial question in resuscitation science, and Maine Medical Center is proud to be on the leading edge of this important research area. We believe the trial results will lead to new therapeutic options for desperately ill patients, and improve the chances that a patient suffering from cardiac arrest will make it home to their loved ones.”
Cardiac Arrest: Can We Improve Outcomes for These Patients?
Dr. Samip Vasaiwala
“PEARL is a critically important study addressing the question of how to best manage patients who experience cardiac arrest The question we hope to answer is whether cardiac arrest patients, regardless of ECG findings, should be taken to the cath lab to evaluate their heart arteries.”