Emory Department of Emergency Medicine and Grady Memorial Hospital are teaming up to offer a new clinical trial aimed at a specific group of cardiac arrest survivors. The new trial will determine the best method of care for people who have an out-of-hospital cardiac arrest, are resuscitated and transported to the Grady Emergency Department by ambulance.
Cardiac arrest occurring outside of the hospital setting affects 300,000 to 400,000 people annually in the United States. Conservatively, only about 10 percent of the patients survive. Eighty percent of patients that survive with favorable neurological outcome present with arrhythmias, or abnormal heart rhythms, such as ventricular tachycardia (VT) or ventricular fibrillation (VF).
Of the estimated 120,000 to 130,000 VT/VF cardiac arrests each year, 70 percent of these cases do not show clinical signs of a heart attack or blockage in the heart’s arteries when an electrocardiogram or ECG is performed. Because no blockage appears on the ECG, those patients may not go directly to the cardiac catheterization lab for treatment.
The Emory/Grady site will be one of about 30 centers in the U.S., and the only site in Georgia, participating in the trial called “ACCESS to the cardiac catheterization lab in patients without ST-segment elevation myocardial infarction resuscitated from out-of-hospital ventricular fibrillation cardiac arrest.” The clinical trial is funded by a $5.5 million grant from the National Heart, Lung, and Blood Institute (NHLBI), a division of the National Institutes of Health.
The ACCESS trial will help determine the best of two standard treatment options currently used: 1) immediate transport to the cath lab once at the emergency department or 2) immediate transport to the Intensive Care Unit (ICU). Following observation, it will be decided if the patient then needs to go to the cath lab. Patients will be randomly selected for the two treatment options.
“The ACCESS trial is an NHLBI-sponsored study that aims to clarify the strategy of initial cardiac catheterization versus initial ICU care in patients with no ST-elevation on their ECG following return of spontaneous circulation after VT/VF cardiac arrest,” says Lekshmi Kumar, MD, assistant professor of emergency medicine at Emory and principal investigator of the ACCESS study at Emory and Grady. “Currently there are no standardized recommendations that dictate care of this subset of patients. This multi-center randomized study would help establish guidelines, thus ensuring uniform evidence-based practice.”
ST-segment elevation myocardial infarctions or STEMI’s result in a complete blockage of a coronary artery. Patients without ST-segment elevation events, brought on by heart arrhythmias where the artery is partially blocked, will be accepted into this clinical trial.
Participants between the ages of 18 to 75 will be enrolled in the ACCESS study as soon as they arrive at Grady Memorial Hospital by ambulance. Because of the timeliness of this study, participants could be enrolled through “Exception from Informed Consent” if they are unconscious and there is no family member or legally-authorized representative to speak with the study team.
Metro-Atlanta residents who choose not to be a part of this study, should they experience an out-of-hospital cardiac arrest and be transported to Grady, can contact the study team at ACCESSstudy@Emory.edu to “opt-out” of the clinical trial. They will receive a bracelet notifying the study team they don’t want to be enrolled in the ACCESS Study.
Importantly, patients arriving at Grady who do have a diagnosed blockage on ECG will not be admitted to the trial and will go directly to the cath lab for treatment.
“Emory University is a leading academic institution with a wide reach, catering to a very diverse population between its different clinical sites and hospitals,” explains Kumar. “Grady Hospital is Georgia's busiest Level 1 trauma center, which sees not only injuries and trauma but cares for many patients with chronic diseases, such as heart disease and diabetes, as well as cancer and stroke.”
Kumar goes on to say, “Participating in a multi-center trial with the heterogeneity of both of these health systems not only helps us contribute important clinical data, but also ensures the results are generalizable to our population.”
Approximately 800 participants will be enrolled nationally during the five-year clinical trial. Participants in the ACCESS trial will be assessed for neurological outcomes following their cardiac arrest and again at discharge. Study participants will undergo an additional neurological assessment three months after their cardiac arrest.
For more information on the ACCESS clinical trial, visit: https://clinicaltrials.gov/ct2/show/NCT03119571?id=NCT03119571&rank=1&load=cart
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Cardiac arrest occurring outside of the hospital setting affects 300,000 to 400,000 people annually in the United States. Conservatively, only about 10 percent of the patients survive. Eighty percent of patients that survive with favorable neurological outcome present with arrhythmias, or abnormal heart rhythms, such as ventricular tachycardia (VT) or ventricular fibrillation (VF).
Of the estimated 120,000 to 130,000 VT/VF cardiac arrests each year, 70 percent of these cases do not show clinical signs of a heart attack or blockage in the heart’s arteries when an electrocardiogram or ECG is performed. Because no blockage appears on the ECG, those patients may not go directly to the cardiac catheterization lab for treatment.
The Emory/Grady site will be one of about 30 centers in the U.S., and the only site in Georgia, participating in the trial called “ACCESS to the cardiac catheterization lab in patients without ST-segment elevation myocardial infarction resuscitated from out-of-hospital ventricular fibrillation cardiac arrest.” The clinical trial is funded by a $5.5 million grant from the National Heart, Lung, and Blood Institute (NHLBI), a division of the National Institutes of Health.
The ACCESS trial will help determine the best of two standard treatment options currently used: 1) immediate transport to the cath lab once at the emergency department or 2) immediate transport to the Intensive Care Unit (ICU). Following observation, it will be decided if the patient then needs to go to the cath lab. Patients will be randomly selected for the two treatment options.
“The ACCESS trial is an NHLBI-sponsored study that aims to clarify the strategy of initial cardiac catheterization versus initial ICU care in patients with no ST-elevation on their ECG following return of spontaneous circulation after VT/VF cardiac arrest,” says Lekshmi Kumar, MD, assistant professor of emergency medicine at Emory and principal investigator of the ACCESS study at Emory and Grady. “Currently there are no standardized recommendations that dictate care of this subset of patients. This multi-center randomized study would help establish guidelines, thus ensuring uniform evidence-based practice.”
ST-segment elevation myocardial infarctions or STEMI’s result in a complete blockage of a coronary artery. Patients without ST-segment elevation events, brought on by heart arrhythmias where the artery is partially blocked, will be accepted into this clinical trial.
Participants between the ages of 18 to 75 will be enrolled in the ACCESS study as soon as they arrive at Grady Memorial Hospital by ambulance. Because of the timeliness of this study, participants could be enrolled through “Exception from Informed Consent” if they are unconscious and there is no family member or legally-authorized representative to speak with the study team.
Metro-Atlanta residents who choose not to be a part of this study, should they experience an out-of-hospital cardiac arrest and be transported to Grady, can contact the study team at ACCESSstudy@Emory.edu to “opt-out” of the clinical trial. They will receive a bracelet notifying the study team they don’t want to be enrolled in the ACCESS Study.
Importantly, patients arriving at Grady who do have a diagnosed blockage on ECG will not be admitted to the trial and will go directly to the cath lab for treatment.
“Emory University is a leading academic institution with a wide reach, catering to a very diverse population between its different clinical sites and hospitals,” explains Kumar. “Grady Hospital is Georgia's busiest Level 1 trauma center, which sees not only injuries and trauma but cares for many patients with chronic diseases, such as heart disease and diabetes, as well as cancer and stroke.”
Kumar goes on to say, “Participating in a multi-center trial with the heterogeneity of both of these health systems not only helps us contribute important clinical data, but also ensures the results are generalizable to our population.”
Approximately 800 participants will be enrolled nationally during the five-year clinical trial. Participants in the ACCESS trial will be assessed for neurological outcomes following their cardiac arrest and again at discharge. Study participants will undergo an additional neurological assessment three months after their cardiac arrest.
For more information on the ACCESS clinical trial, visit: https://clinicaltrials.gov/ct2/show/NCT03119571?id=NCT03119571&rank=1&load=cart
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