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

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Other
  • Study Primary Completion Date: June 30, 2023

Detailed Description

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.

Arms, Groups and Cohorts

  • Phlegm-heat syndrome in ischemic stroke
    • 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
    • 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

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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).

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Dongzhimen Hospital, Beijing
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ying Gao, Professor – Dongzhimen Hospital, Beijing
  • Overall Contact(s)
    • Xinxing Lai, 8615901111280, new-star@163.com

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