Molecular Network Characteristics of Phlegm-heat Syndrome in Ischemic Stroke Based on Multi-omics Integrated Analysis

Study Overview
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Brief Summary
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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
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This is a cohort study in patients with ischemic stroke. The demographic characteristics, 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.

Official Title
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Molecular Network Characteristics of Phlegm-heat Syndrome in Ischemic Stroke Based on Multi-omics Integrated Analysis

Conditions
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Ischemic Stroke, Acute

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute ischemic stroke, were confirmed by magnetic resonance imaging (MRI). Symptom onset within 72 hours. Diagnosis of phlegm-heat syndrome or non-phlegm-heat syndrome. Male or female ≥ 50 years and ≤ 80 years. With written informed consent. Exclusion Criteria: Planned or already receiving intravenous thrombolysis or endovascular treatment. Acute infectious diseases or acute exacerbations of chronic diseases within one month before enrollment. Patients with previous stroke. Renal or hepatic insufficiency, tumors, immune diseases, severe underlying diseases. Other conditions that may affect the collection and evaluation of clinical information (e.g., severe aphasia, mental illness).

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Phlegm-heat syndrome in ischemic stroke<br>Phlegm-heat syndrome: the score of Phlegm-dampness syndrome ≥10 with the score of Internal fire syndrome ≥10 in Diagnostic Scale for Syndrome Elements of Ischemic Stroke | |
| Non-phlegm-heat syndrome in ischemic stroke<br>Non-phlegm-heat syndrome: the score of Phlegm-dampness syndrome <10 with the score of Internal fire syndrome <10 in Diagnostic Scale for Syndrome Elements of Ischemic Stroke | |
| Healthy subjects<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Omic biomarkers associated with phelm-heat syndrome in ischemic stroke | Sensitivity, specificity, and area under the ROC curve of omic biomarkers of Phlegm-heat syndrome in ischemic stroke. | baseline |