Ischemic Stroke, Acute
Conditions
Brief summary
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.
Detailed description
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.
Interventions
Guideline-based treatment includes anti-platelet therapy, control of vascular risk factors, and so on.
Sponsors
Study design
Eligibility
Inclusion criteria
* 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.
Exclusion criteria
* 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity, specificity, and area under the ROC curve of molecular features of Phlegm-heat syndrome in ischemic stroke | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients independent | 90 days | Proportion of patients independent is defined as the modified Rankin Scale score of 0, 1, or 2. |
| National Institute of Health Stroke Scale | Baseline, 7 days and 10 days after stroke onset. | The National Institute of Health Stroke Scale (NIHSS) ranges from 0 to 42, with higher scores indicating more severe neurological deficits. |
Countries
China