Clinical Trials

Current Trials

ACCESS - Early versus Standard to Cardiac Catheterization Lab Activation in Resuscitated Cardiac Arrest Survivors with Non-ST Segment Elevation MI

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

This announcement serves as public notification of a Cardiac Arrest research study that will begin January 2018 and will be performed in Minneapolis and St Paul Minnesota (and several other US locations) using the DHHS research regulations allowing exception to informed consent in emergency research circumstances.  The study will include all adult victims of ventricular fibrillation out-of-hospital cardiac arrest (an irregular heart rhythm that does not pump blood) who are transported to participating Twin Cites hospitals.  All patients will receive standard resuscitation care.  The only difference for this study will be that half of the patients will be randomized (a 50 - 50 chance, similar to “flipping a coin”) to go directly to the cardiac catheterization lab (CCL) and the other half will be transported directly to the Intensive Care Unit (ICU).

Cardiac arrest is the sudden loss of pulse and breathing. Cardiopulmonary resuscitation (CPR) is typically performed until normal heart function can be restored. The purpose of this research study is to determine if more of these patients do better if initially transported to the CCL or initially transported to the ICU for consultation by a cardiologist. Patients who are known to have a clot in their heart arteries are taken to the “cardiac cath lab” in order to have an invasive procedure (called “catheterization”) to remove the clot and restore blood flow to their heart. Patients are known to have a clot if there are certain signs on their electrocardiogram (ECG). However, previous research has shown that patients that have an out-of-hospital cardiac arrest due to ventricular fibrillation (an irregular heart rhythm that does not pump blood) may be likely to have a clot in their heart arteries but not have signs of a clot on their ECG.

All research contains risks.  Risks common to both treatments are infection, damage to the liver, damage to the heart with low blood pressure, damage to multiple organs in the body, seizures, repeated cardiac arrest, survival to hospital discharge with decreased function, and death. Risks associated with catheterization are heart attack (caused by the catheterization), stroke (caused by the catheterization), injury to the catheterized artery, tear in the heart or heart artery, fluid or blood around the heart, bleeding requiring blood transfusion, kidney damage (caused by contrast dye), and death (as a direct complication of catheterization). The risks of these complications generally occur less than 1 out of 100 times. Patients who are initially transported to the CCL have an increased risk of having catheterization performed without having an actual clot in their heart arteries. Patients who are initially transported to the ICU have an increased risk of delayed catheterization to remove a potential clot in their heart arteries.

The information that is obtained from this study may be useful scientifically and possibly helpful to others.  The benefit that may reasonably be expected from participating in this study is improved treatments for out-of-hospital ventricular fibrillation cardiac arrest or an increased chance of survival, but these potential benefits are not guaranteed.  There are no financial risks or benefits for study participation.  For this study, both treatment arms are standards of care. The study team will make every effort to protect your personal health information and keep it confidential, but it is possible that an unauthorized person might see it.  The scientific or medical information not identifiable with a patient resulting from the study will be presented at meetings and published so that the information can be useful to others. 

The DHHS has implemented regulations allowing an exception to informed consent under emergency research circumstances where acquiring written informed consent is impossible and there is reasonable scientific evidence to suggest a possible benefit from a new intervention. These regulations require public notification to inform the community that a research project will be done that may impact members of the local population.  This notification must be made prior to the initiation of the study, which will begin January 2018, and continue through 2021.  Public notification will also occur after the study is completed.

This study meets the regulatory federal guidelines for exception to informed consent under emergency circumstances because informed consent cannot be obtained from a victim of sudden cardiac arrest.  Interested parties with questions or concerns or those who do not wish to participate in this trial and would like to request an opt-out bracelet, are encouraged to contact the principal investigator, Demetris Yannopoulos, MD, or visit the WEB site at https://www.dom.umn.edu/divisions/cardiovascular/division-sections/resuscitation-clinical-research/access.   Feedback from the community may be used to further modify the design of the study.  

 

ESETT - Established Status Epilepticus Treatment Trial

ESETT is a multicenter, randomized, double-blind, comparative effectiveness study of fos-phenytoin, levetiracetam, and valproic acid in subjects with benzodiazepine-refractory status epilepticus (people who do not stop seizing after 5 minutes). Emergency department care of Established Status Epilepticus (ESE) in the US is not the same everywhere. Doctors use their judgment, but what treatment will work best is not known. The purpose of this study is to find out which of three commonly used medicines given in the emergency department for ESE is safer and more effective. Normally, researchers get permission before a person can be included in a study. A person having a seizure will not be able to give consent. Since a seizure that will not stop on its own must be treated quickly, there will not be enough time to locate and talk to the person’s legal representative about the study. All patients will be enrolled in the study without his/her legal representative’s consent. This is called “Exception from Informed Consent” (EFIC). Once the representative is located or the patient wakes up, they will be told about the study and asked to give their permission to continue in the study.

If you would like to opt out of the possibility of being enrolled in the ESETT trial, please call 612-624-8280 for more information.

Learn more about the ESETT trial.

Minnesota NETT Hub participating hospitals:

  • Fairview Southdale Hospital
  • Hennepin County Medical Center
  • Mayo Clinic - St. Mary's Campus
  • Regions Hospital
  • University of Minnesota Masonic Children's Hospital
  • University of Minnesota Medical Center - Fairview

POINT - Platelet-Oriented Inhibition in New TIA and minor ischemic stroke Trial

POINT is a randomized, double-blind, multicenter trial to determine whether clopidogrel 75mg/day (after a loading dose of 600mg) is effective in improving survival free from major ischemic vascular events (ischemic stroke, myocardial infarction, and ischemic vascular death) at 90 days when initiated within 12 hours time last known free of new ischemic symptoms of TIA or minor ischemic stroke in subjects receiving aspirin 50-325mg/day.

Learn more about the POINT trial.

Minnesota NETT Hub participating hospitals:

  • Abbott Northwestern Hospital
  • Hennepin County Medical Center
  • Mayo Clinic
  • Regions Hospital
  • United Hospital
  • University of Kansas Medical Center
  • University of Minnesota Medical Center - Fairview

SHINE - Stroke Hyperglycemia Insulin Network Effort

This is a multicenter, prospective, randomized, controlled trial, with blinded outcomes. It aims to determine the efficacy and provide further safety data on the use of insulin infusion therapy for glucose control in hyperglycemic acute ischemic stroke patients. Treatment with insulin infusion will be given within 12 hours of symptom onset. The primary outcome to be assessed at 90 days will be the difference in favorable outcome measured by the Modified Rankin Scale score in the insulin infusion group compared to the control group. The rates of symptomatic hypoglycemia with prolonged neurological worsening as well as asymptomatic hypoglycemia will be assessed. The secondary outcomes will assess additional neurological and functional outcomes. This highly collaborative research program is nearly guaranteed to advance the field of stroke care.

Learn more about the SHINE trial.

Minnesota NETT Hub participating hospitals:

  • Hennepin County Medical Center
  • University of Kansas Medical Center
  • University of Minnesota Medical Center - Fairview

 

Completed Trials

ATACH-II - Antihypertenseive Treatment of Cerebral Hemorrhage

ATACH-II is an international trial of very early blood pressure lowering with IV nicardipine to two different systolic blood pressure targets in hypertensive patients with moderate sized parenchymal intracerebral hemorrhage.

Learn more about the ATACH-II trial.

Minnesota NETT Hub participating hospitals:

  • Essentia Health - Duluth
  • Fairview Southdale Hospital

Community VOICES (3): Community VOICES on informed consent in emergency situation 

The VOICES trial reports and anaylzes the various methods of implementing exception from informed consent trials, from trial start up to close. VOICES is currently the only non-interventional, non-NETT trial in the Department of Emergency Medicine.

Learn more about the VOICES trial.

 

ProTECT - Progesterone for Traumatic Brain Injury: Experimental Clinical Treatment

Traumatic brain injury (TBI) is a major cause of premature death and disability worldwide. With the exception of mannitol, no therapy has been found to be effective in reducing mortality and improving functional outcomes. Progesterone is a steroid found to have powerful neuroprotective properties in multiple animal models of brain injury. Based on encouraging pilot clinical trial results, the ProTECT trial was designed to determine the efficacy and confirm safety of this treatment in adults with moderate to severe TBI. Patients were enrolled into this study within 4 hours of injury. This study was conducted exclusively at Level 1 Trauma Centers.

Learn more about the ProTECT trial.

Minnesota NETT Hub participating hospitals:

  • Hennepin County Medical Center
  • North Memorial Medical Center
  • Regions Hospital

ALIAS - Albumin in Acute Stroke Trial

Stroke is the leading cause of death and disability in the United States. The purpose of the ALIAS trial is to evaluate the effectiveness of high-dose, intravenous human serum albumin.  Human serum albumin is a natural protein already in clinical use for a variety of indication. In animal laboratory studies it has been shown that it reduces the size of the infarction (amount of tissue death) in the brain and improves neurological function after a stroke and also decreases or eliminates the brain swelling that may occur; these effects may reduce or prevent the brain damage resulting from a stroke in humans.

Learn more about the ALIAS trial.

Minnesota NETT Hub participating hospitals:

  • Fairview Southdale Hospital
  • Hennepin County Medical Center
  • University of Minnesota Medical Center - Fairview

RAMPART - Rapid Anticonvulsant Medication Prior to Arrival Trial

Status epilepticus, a condition of persistent seizures that do not stop, is a neurologic emergency associated with death and significant disability. Paramedics treat status epilepticus with anti-seizure medicine, but giving medicine through a vein can be difficult or slow in a seizing patient. This study will determine (1) if the anti-seizure drug midazolam given as a shot in the muscle stops seizures as well as the anti-seizure medicine lorazepam given directly into a vein, and (2) the rapidity and safety of these two medicines given in these different ways.

Patient enrollment began on Monday July 20, 2009 within the Hennepin EMS service only. EMS personnel responding to calls for patients with Status Epilepticus were trained in the RAMPART protocol and evaluated patients for possible enrollment in this emergency medicine research study. Enrollment was completed January 2011. This study's results were published in the New England Journal of Medicine, February 16, 2012, entitled: Intramuscular versus Intravenous Therapy for Prehospital Status Epilepticus.

Learn more about the RAMPART trial.

Minnesota NETT Hub participating hospitals:

  • Abbott Northwestern Hospital
  • Fairview Southdale Hospital
  • Hennepin County Medical Center
  • Park Nicollet Methodist Hospital
  • University of Minnesota Medical Center - Fairview