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

Recruiting

• Conditions: Ischemic Stroke, Acute

• Registration Number: NCT05626296
• Lead Sponsor: Dongzhimen Hospital, Beijing

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 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.

Study Timeline

• Study Start: 2022-11-14
• Study First Submitted: 2022-11-14
• Study First Submitted QC: 2022-11-19
• Study First Posted: 2022-11-23
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-17
• Last Update Posted: 2024-06-20
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Dongzhimen Hospital; 🇨🇳 Beijing, Beijing, China