Molecular Characteristics of Phlegm-heat Syndrome in Ischemic Stroke

Not yet recruiting

• Conditions: Ischemic Stroke, Acute
• Interventions: Drug: Guideline-based treatment

• Registration Number: NCT06470477
• 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 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.

Study Timeline

• Study First Submitted: 2022-11-14
• Status Verified: 2024-06
• Study First Submitted QC: 2024-06-17
• Last Update Submitted: 2024-06-17
• Study Start: 2024-06-20
• Study First Posted: 2024-06-24
• Last Update Posted: 2024-06-24
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 84

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Phlegm-heat syndrome	Guideline-based treatment	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.
Non-phlegm-heat syndrome	Guideline-based treatment	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Dongzhimen Hospital; 🇨🇳 Beijing, Beijing, China