Prediction Model for the Recanalization Outcome Evaluation of Ischemic Stroke Using Multimodal CT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 862
- 试验地点
- 1
- 主要终点
- 90-day functional outcome
研究概览
简要总结
Prediction model for the Recanalization OuTcome Evaluation of ischemic stroke using multimodal CT (PROTECT) study was a multicenter prospective observational study that recruited patients from 13 centers located in 10 provinces across China. The study was to assess the effects of novel imaging biomarkers/ imaging patterns based on multimodel CT for patients selection and outcome prediction in acute ischemic stroke.
详细描述
Patients Patients with cerebral ischemia symptoms of anterior circulation or posterior circulation onset in 24 hours were included. A neurological evaluation (Modified Rankin Scale and NIHSS); physical examination, including measurement of weight (kg) and vital signs (supine systolic and diastolic blood pressure); time from symptom onset to enrollment were recorded.
Imaging protocols:
CT scan protocols: Non-contrast computed tomography(NCCT) , computed tomography angiography(CTA), computed tomography perfusion(CTP)
Contrast agent:
CTA: Omniscan 40-50ml, 5ml/s; saline solution 50ml, 5ml/s
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cerebral ischemic sympton with onset in 24 hours
- •All CT examination performed according to study protocol
- •Signed informed consent obtained from the patient or patient's legally authorized representative
排除标准
- •Acute intracranial hemorrhage
- •Pre-existing medical, the neurological, or psychiatric disease that would confound the neurological, functional, or imaging evaluations
- •Pregnancy
- •Known allergy to iodine previously refractory to pretreatment medications
- •Renal Failure (serum creatinine > 2.0 or Glomerular Filtration Rate < 30)
- •History of severe kidney disease as an adult, including tumor or transplant surgery, or family history of kidney failure
- •Severe cardiac insufficiency
结局指标
主要结局
90-day functional outcome
时间窗: 90 days after symptom onset
Assessed by modified Rankin Scale with scores ranging from 0 (no symptoms) to 6 (death)
次要结局
- Percentage of Hemorrhagic Transformation(within 7 days after symptom onset)
- Final infarction volume(within 30 days after symptom onset)
研究者
Xin Lou
Principal Investigator
Chinese PLA General Hospital