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ACCESS Study Public Announcement

Public Notification of an Exception to the Requirements for Informed Consent Under Emergency Circumstances for a Cardiac Arrest Research Study

This announcement serves as pubic notification of a cardiac arrest research study that will begin January 2019 and will be performed at Virginia Commonwealth University in Richmond, Virginia (and several other locations in the United States) using the Department of Health and Human Services research regulations allowing exception to informed consent in emergency research circumstances. The study will include adult persons having a cardiac arrest (medical condition where the heart stops beating blood to the brain and other organs of the body that results in death unless able to be reversed) successfully treated with a defibrillator shock and transported to VCU Health System. All patients will receive standard resuscitation care.  Cardiac arrest is often caused by a blockage in one or more of the arteries supplying blood to the heart commonly known as a heart attack. Blockages causing heart attacks must be treated urgently with a heart catheterization, ideally within the first 90 minutes, to prevent significant heart damage. Typically, heart attacks are diagnosed by certain findings on an electrocardiogram, or ECG, performed when the patient arrives in the Emergency Department. After cardiac arrest however, heart attacks cannot reliably be identified by the ECG and therefore can go undetected and untreated. Most patients whose heart has been restarted after a cardiac arrest are unconscious and in a coma so they are unable to provide medical information. Most patients who come out of the coma after several days will then undergo this heart catheterization to look for blockages but by this time the damage may have already been done to the heart muscle. The purpose of this research study is to determine if more of these patients do better if they are taken to the heart catheterization at the time of admission. Both strategies (early versus late heart catheterization) are currently used clinically and both are considered the standard of care, therefore all patients will receive the standard of care treatment. This study will try to determine which standard treatment is better. Patients will be divided randomly with a 50-50 chance, similar to “flipping a coin” to go directly to the heart catheterization lab versus directly to the Intensive Care Unit to continue to receive normal cardiac arrest care.

Since patients are often in a coma after cardiac arrest due to brain injury from when the heart was not working, they may not be able to give consent. Attempts will be made to contact the patients legally authorized representative to obtain consent for this research study. Since the early heart catheterization must be performed within 90 minutes from the time of admission to result in the most benefit, if the legally authorized representative cannot be contacted to provide consent that would allow the procedure to be done within this timeframe, the patient will be enrolled into the study under the Department of Health and Human Services regulations allowing an exception to informed consent under emergency research circumstances. These regulations require public notification to inform the community that a research project will be done that may impact members of the local population.

Interested persons wishing more information, having questions or concerns, or who do not wish to participate in this trial should they experience a cardiac arrest and would like to request an opt-out bracelet, are encouraged to visit https:/z.umn.edu/accesstrial or email us at: access@vcuhealth.org, or phone us at 804 – 828 – 6047.

Completed Research Support

 

The Weil Institute has obtained long -term contracted studies from Zoll Medical, Philips Healthcare, and Schiller Medical over the past 15years in excess of over half a million dollars a year.

 

11IRG4870001                                       Tang (PI)                                                      01/01/2011-12/31/2012

Pharmacologically induced hypothermia during and following CPR

The goal of this project was to investigate whether hypothermia could be induced with the pharmacologic agents.

Role: PI

W81XWH-11-2-0017                             Tang (PI)                                                      11/23/2010-12/22/2011

Monitoring Tissue Ischemia After Potentially Life Threatening Post-Traumatic Injuries

Role: PI

DM090446                                              Tang (PI)                                                      05/20/2010-05/19/2012

Monitoring tissue ischemia after potential life-threatening traumatic injuries.

The goal of this project was to investigate tissue PCO2 as a sensitive indicator of tissue ischemia during trauma.

Role: PI

R13HL09386-01                                    Tang (PI)                                                       06/18/2009-06/17/2010

2009 annual wolf creek conference on resuscitation

This was a conference grant to support the Wolf Creek Conference.

Role: PI

R13HL090057-01                                   Tang (PI)                                                      04/13/2007-04/12/2008

2007 annual wolf creek conference on resuscitation

This was a conference grant to support the Wolf Creek Conference.

DAMD17-02-1-0696                           Weil (PI)                                                          08/15/2002-08/14/2004

Quantitative mechanistic model of sublingual PCO2 as an index of shock severity and resuscitation success.

The goal of this project was to investigate whether the changes in sublingual PCO2 reflect changes in tissue blood flow during hemorrhage and hemorrhagic shock.

Role: Co-PI

                                                            Tang (PI)                                                          01/01/2002-12/30/2004

Opioid receptor activation for cardiac resuscitation

The goal of this project was to investigate the effects of opioid receptor agonist on post resuscitation myocardial function.

Role: PI

RO1 HL54322                                     Weil (PI)                                                          05/01/1997-04/30/2004

Adrenergic agents for cardiopulmonary resuscitation

The goal of the project was to investigate the optimal vasopressor agents for cardiopulmonary resuscitation.

Role: Co-PI

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