Molecular Characteristics of Phlegm-heat Syndrome in Ischemic Stroke: A Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Sensitivity, specificity, and area under the ROC curve of molecular features of Phlegm-heat syndrome in ischemic stroke
研究概览
简要总结
The molecular characteristics of ischemic stroke with phlegm-heat syndrome and candidate biomarkers were identified based on multi-omics data. The main purpose of this study is to validate the molecular characteristics and biomarkers of phlegm-heat syndrome in ischemic stroke, and to demonstrate the association of biomarkers with clinical outcomes.
详细描述
This is a cohort study in patients with acute ischemic stroke. The demographic characteristics, Traditional Chinese Medicine (TCM) syndromes, and other baseline information will be recorded. At the same time, baseline peripheral blood will be collected. These participants will be followed up to 90 days of onset, and 90-day modified Rankin scale (mRS) scores will be assessed. The collected blood samples will be tested by multi-factor detection technology for candidate biomarkers.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute ischemic stroke.
- •Symptom onset within 72 hours.
- •Diagnosis of phlegm-heat syndrome or non-phlegm-heat syndrome.
- •Male or female ≥18 years and ≤ 80 years.
- •With written informed consent.
排除标准
- •Acute infectious diseases or acute exacerbations of chronic diseases within one month before enrollment.
- •Patients has previous stroke.
- •Other conditions that lead to motor dysfunction (e.g., severe osteoarthritis, rheumatoid arthritis).
- •Renal or hepatic insufficiency, tumors, immune diseases, severe underlying diseases.
- •Other conditions that affect the collection and evaluation of clinical information (e.g., severe aphasia, mental illness).
研究组 & 干预措施
Phlegm-heat syndrome
Phlegm-heat syndrome: the score of "Phlegm-dampness syndrome" ≥10 and the score of "Internal fire syndrome" ≥10 in Diagnostic Scale for Syndrome Elements of Ischemic Stroke.
干预措施: Guideline-based treatment (Drug)
Non-phlegm-heat syndrome
Non-phlegm-heat syndrome: the score of "Phlegm-dampness syndrome" <10 and the score of "Internal fire syndrome" <10 in Diagnostic Scale for Syndrome Elements of Ischemic Stroke.
干预措施: Guideline-based treatment (Drug)
结局指标
主要结局
Sensitivity, specificity, and area under the ROC curve of molecular features of Phlegm-heat syndrome in ischemic stroke
时间窗: Baseline
Sensitivity, specificity, and area under the ROC curve of molecular features of Phlegm-heat syndrome in ischemic stroke. The molecular characteristics of phlegm-heat syndrome in ischemic stroke include but are not limited to matrix metalloproteinase 9, mitogen-activated protein kinase 1, interleukin 6, and tumor necrosis factor.
次要结局
- Proportion of patients independent(90 days)
- National Institute of Health Stroke Scale(Baseline, 7 days and 10 days after stroke onset.)
研究者
Ying Gao
Professor
Dongzhimen Hospital, Beijing