Evaluation, Pathogenesis, and Treatment of Patients With or at Risk for Cerebrovascular Disease (A Natural History/Disease Pathogenesis Protocol)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 4,000
- 试验地点
- 3
- 主要终点
- Prevalence and type of abnormalities seen on neuroimaging as a function of time from acute insult
研究概览
简要总结
The purpose of this study is to learn more about stroke and obtain information that may serve as the basis for future investigations. It will 1) establish a registry of patients with cerebrovascular disease (stroke); 2) characterize the natural history of acute stroke and transient ischemic attacks (TIA)-an interruption of blood flow to the brain that causes stroke symptoms for a short period of time); and 3) evaluate the data to generate ideas for future studies.
Patients 18 years of age or older with suspected acute stroke or TIA may be eligible for this study. Subjects will be recruited from patients who present with stroke at the emergency department of Suburban Hospital in Bethesda, Maryland.
The study will gather data collected from diagnostic and laboratory tests the patient undergoes as part of standard medical care, including findings of medical and neurological examinations and other tests. In addition, studies will be done for research purposes only to gather data about stroke and TIA. These may include the following:
- Blood and urine tests not more than 2 tablespoons of blood will be drawn for various tests.
- Electrocardiogram (EKG) (heart tracing)-electrodes placed on the chest wall detect the heartbeat and heart rhythm.
- Computed tomography (CT) scan of the head-specialized X-rays are used to obtain images of the brain.
- Magnetic resonance imaging (MRI) of the brain-a strong magnetic field and radio waves are used to produce images that provide information about the brain tissue and blood vessels.
- Transcranial Doppler (TCD)-sound waves are used to image the arteries of the brain and neck.
- Echocardiogram-sound waves are used to image the heart and evaluate heart function.
Patients may be asked to return to Suburban Hospital for follow-up testing in 1, 3, and/or 12 months, when some of these tests may be repeated to assess changes over time
详细描述
Study Description:
This is a natural history/disease pathogenesis protocol for evaluation of patients with or at risk of acute stroke, transient ischemic attack (TIA), or other disturbances of cerebrovascular circulation. The purpose of this protocol is to generate natural history data to serve as the basis for future hypothesis-driven protocols as well as to contribute to the clinical and physiological understanding of cerebrovascular disease through the description of disease manifestation and the relationship among clinical, hematologic, and radiologic variables, as well as identifying potential subjects for future studies on stroke and other cerebrovascular diseases.
Objectives:
- To establish a registry of subjects with cerebrovascular disease including clinical, laboratory, and radiological variables associated with hemorrhagic and ischemic stroke, TIA, and other disturbances of cerebrovascular circulation.
- To characterize the natural history of acute stroke, TIA, and other disturbances of cerebrovascular circulation on these variables.
- To evaluate the relationship among these variables by exploratory analyses and to generate hypotheses for future testing.
- To identify potential subjects for research studies on stroke and other cerebrovascular diseases.
Endpoints:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •INCLUSION CRITERIA:
- •In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- •Presented to participating study site (ED, ICU, or inpatient unit) with or at risk of acute stroke, TIA, or other disturbances of cerebrovascular circulation
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •Subjects with contraindication to MRI scanning will be excluded from any testing which involves the use of MRI. The contraindications include subjects with the following devices or conditions:
- •Central nervous system aneurysm clips
- •Implanted neural stimulator
- •Implanted cardiac pacemaker or defibrillator
- •Cochlear implant
- •Ocular foreign body (e.g. metal shavings)
- •Insulin pump
- •Metal shrapnel or bullet
- •Any implanted device that is incompatible with MRI
- •Subjects with a condition precluding entry in the scanner (e.g. morbid obesity, Claustrophobia, etc.) will not be included in the MRI portion of this study.
研究组 & 干预措施
Patients
Patients with acute stroke symptoms
结局指标
主要结局
Prevalence and type of abnormalities seen on neuroimaging as a function of time from acute insult
时间窗: Post-acute, 24 hours, 5 days/discharge, 30 days
Neuroimaging abnormalities, such as:-Imaging positive for acute ischemic cerebral vascular syndrome ( AICS positive )-Presence of a lesion on diffusion, perfusion, and mismatch between the two-Evidence of a vascular occlusion on MR angiography-Evidence of a thrombus or hemorrhage on T2\* GRE imaging-Blood-brain barrier disruption as evidence by "HARM"-The evolution of these markers with time and treatment
次要结局
- Clinical outcome measured using modified Rankin Scale and Barthel Index(5 days/discharge, 30 days, 3 months, 6 months, 12 months)
- Stroke severity as measured by NIHSS as a function of time since index event(Post-acute, 24 hours, 5 days/discharge, 30 days, 3 months, 6 months, 12 months)
- Gene expression profiles and biomarker levels obtained from blood samples(Post-acute, 24 hours, 5 days/discharge, 30 days, 3 months, 6 months, 12 months)