University of Arizona Sarver Heart Center researchers are seeking community input on a clinical trial that requires qualified patients to be enrolled when they are unconscious and unable to give consent. This study may improve care for all cardiac arrest patients.
Cardiac arrest is a major public health issue, claiming nearly 300,000 lives in the United States each year. Survival rates are poor. Cardiac arrest occurs when a person’s heart suddenly stops pumping blood. In adults, this often occurs following a heart attack.
- Only 40 percent of the people who have an out-of-hospital cardiac arrest are resuscitated and brought alive to the hospital.
- Of those 40 percent brought to the hospital, only one in four survives to go home.
When a cardiac arrest patient makes it to the hospital alive, doctors run an electrocardiogram (ECG).
- If the electrocardiogram (ECG) shows changes of a heart attack, cardiac arrest patients have a coronary angiogram (heart catheterization).
- When the ECG does not show an obvious heart attack, the timing of the heart catheterization is decided on a case-by-case basis by treating doctors.
Karl B. Kern, MD, is leading a study, called the PEARL Study, to answer the question: Does an early heart catheterization improve survival, even when the ECG does not show an obvious heart attack?
This study falls under FDA Guidelines – Exception from Informed Consent for Emergency Research. The Sarver Heart Center needs to learn what the community thinks about this research before it starts this study. You can help by completing this survey. This helps us know our efforts to notify the community were received and whether or not you consider this study acceptable to the community and to you. A cardiac arrest patient who arrives at the hospital will be unconscious and we may not have time to reach a family member to obtain consent to enroll the patient in the study. The doctor will decide if the patient is qualified and enroll the person in the study.
An Institutional Review Board responsible for human subjects research at The University of Arizona reviewed this research project and found it to be acceptable, according to applicable state and federal regulations and University policies designed to protect the rights and welfare of participants in research.
If you would not want to participate in the PEARL Study, the survey gives you an opportunity to opt out. Opting out indicates to the investigator that you declined to be part of the study. Whether you would want to participate or opt out, please complete the survey and let us know your opinion about the PEARL Study.
Who is leading this research?
Karl B. Kern, MD
Professor, Medicine and Co-director
University of Arizona Sarver Heart Center
Cardiopulmonary Resuscitation Research Group
“Currently only cardiac arrest patients with certain ECG findings after resuscitation are recommended for emergent catheterization of the artery to look for blockages (coronary angiography). This study will examine if other post-cardiac arrest patients might also benefit from early coronary angiography. We believe the answer to this question is extremely important as we continue to strive to improve long-term outcomes for cardiac arrest victims,” said Dr. Kern.
Kwan S. Lee, MD
Banner – University Medical Center South
Director, Cardiac Catheterization Lab
“We are excited to have Southern Arizona lead in this important national study looking at new treatments for patients with out-of-hospital cardiac arrest and the effort to further improve long-term survival,” said Dr. Lee.
The Arizona Department of Health Services, Arizona Biomedical Research Commission awarded Dr. Kern a three-year grant to conduct this study. This research also is funded in part by the Steven M. Gootter Foundation and the Sarver Heart Center’s Gordon A. Ewy, MD, Resuscitation Research Endowment. Dr. Kern will lead a group of physicians at the Banner – University Medical Center, Tucson and South Campuses, Vanderbilt University Medical Center, Maine Medical Center and Minneapolis Heart Institute.