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Molecular Characteristics of Phlegm-heat Syndrome in Ischemic Stroke

Molecular Characteristics of Phlegm-heat Syndrome in Ischemic Stroke: A Cohort Study

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06470477
Enrollment
84
Registered
2024-06-24
Start date
2024-06-20
Completion date
2024-12-31
Last updated
2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Stroke, Acute

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

Dongzhimen Hospital, Beijing
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

MeasureTime frameDescription
Sensitivity, specificity, and area under the ROC curve of molecular features of Phlegm-heat syndrome in ischemic strokeBaselineSensitivity, 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

MeasureTime frameDescription
Proportion of patients independent90 daysProportion of patients independent is defined as the modified Rankin Scale score of 0, 1, or 2.
National Institute of Health Stroke ScaleBaseline, 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

Contacts

Primary ContactXinxing Lai, M.D.
new-star@163.com8615901111280

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026