Cardiac Arrest Recovery EEG Study (CARES)
Phase IIB Study of Novel Quantitative Neurodiagnostic Technology in the Early Period After Cardiac Arrest
研究概览
详细说明
Cardiac arrest claims over 450,000 lives per year in the United States alone. There is a high incidence of neurological complications amongst survivors, and these represent the leading cause of morbidity.
Over the past several years, the care of these patients has been improved via the introduction of new systemic as well as neurospecific therapies. Speed of institution of therapy appears to be an important factor affecting efficacy. Yet, in the crucial initial hours to days post-arrest, assessment of neurological status in these patients is essentially non-existent.
Thus, there is a need for an objective validated tool to assess prognosis and to track neurological status in the early recovery period. In response to this need, we have developed an EEG based Cortical Health Index (CHI). This EEG-based index incorporates multiple weighted parameters derived from 2 channels (4 scalp electrodes + 1 ground electrode) which are related to neurologic functional recovery. The strength and uniqueness of this approach results from consideration of both the temporal as well as the spectral domains of EEG. Our Phase II results demonstrate that CHI measured within the first 6-hours post-arrest resuscitation is strongly correlated with clinical outcome at hospital discharge in a 30-patient cardiac arrest study. Together with our industry collaborator, we now propose to pursue regulatory approval of the CHI Monitor. Our plan involves a prospective clinical trial involving 4 centers and 100 patients (64 Cardiac Arrest Patients and 36 patients undergoing ICD placement as controls). We will test the ability of CHI to: 1) provide early prediction of subsequent neurological functional outcome of cardiac arrest patients, and 2) provide real-time tracking of brain injury and response to therapy. Successful completion of this project is defined by FDA clearance of the CHI Monitor.
It is our goal that the CHI Monitor will identify patients who could benefit from aggressive intervention, and then track the response to the therapy. Providing this information to the treating physician in the immediate post-resuscitation period represents a major change in care delivery for the cardiac arrest survivor.
研究类型
注册 (预期的)
联系人和位置
学习地点
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Maryland
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Baltimore、Maryland、美国、21224
- 招聘中
- Johns Hopkins Bayview Medical Center
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首席研究员:
- Romergryko Geocadin, MD
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Baltimore、Maryland、美国、21187
- 招聘中
- Johns Hopkins Hospital
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接触:
- Daniel F Hanley, MD
- 电话号码:410-614-6996
- 邮箱:dhanley@jhmi.edu
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首席研究员:
- Romergryko Geocadin, MD
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Virginia
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Richmond、Virginia、美国、23298
- 尚未招聘
- Virginia Commonwealth University
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接触:
- Mary Ann Peberdy, MD
- 电话号码:804-828-4571
- 邮箱:mpeberdy@aol.com
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首席研究员:
- Mary Ann Peberdy, MD
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Wisconsin
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Milwaukee、Wisconsin、美国、53226
- 招聘中
- Medical College of Wisconsin at Froedtert Memorial Luthern Hospital Clinics - Neurology
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接触:
- Michel Torbey, MD,MPH
- 电话号码:414-805-5343
- 邮箱:mtorbey@mcw.edu
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首席研究员:
- Michel Torbey, MD, MPH
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
Cardiac Arrest:
Patients 18 years and older:
- with cardiac arrest in the hospital and successfully resuscitated, or
- with cardiac arrest out of the hospital and successfully resuscitated
ICD patients:
Patients 18 years and older:
- Who are undergoing elective procedure in the electrophysiology laboratory for placement of a cardiac defibrillator and who will most likely undergo induction of ventricular arrhythmia as part of the procedure
Exclusion Criteria:
Cardiac Arrest:
- Cardiac arrest and a known pre-existing cerebral pathology such as brain tumor, cerebral hemorrhage, encephalitis or immediately post-op neurosurgery.
- CNS infection
- Skull defects and scalp diseases that are not amenable to standard EEG testing
ICD patients:
- Known pre-existing cerebral pathology such as brain tumor, cerebral hemorrhage, encephalitis or immediately post-op neurosurgery.
- CNS infection
- Skull defects and scalp diseases that are not amenable to standard EEG testing
学习计划
研究是如何设计的?
设计细节
合作者和调查者
合作者
调查人员
- 首席研究员:Neil S Rothman, PhD、Infinite Biomedical Technologies - Study Sponsor
- 首席研究员:Romergryko Geocadin, MD、Johns Hopkins University
- 首席研究员:Michel Torbey, MD, MPH、Medical College of Wisconsin
- 首席研究员:Mary Ann Peberdy, MD、Virginia Commonwealth University
研究记录日期
研究主要日期
学习开始
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- R44HL070129 (美国 NIH 拨款/合同)
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