Molecular Characteristics of Phlegm-heat Syndrome in Ischemic Stroke

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorDongzhimen Hospital, Beijing

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Patients aged 18 to 80 years with acute ischemic stroke within 72 hours of onset.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Guideline-based treatment

    Drug

    Guideline-based treatment includes anti-platelet therapy, control of vascular risk factors, and so on.

Treatment groups

84 Participants
are divided into 2 treatment groups
Group A: Phlegm-heat syndrome1 intervention
Group B: Non-phlegm-heat syndrome1 intervention

Trial outcomes

Primary outcomes

1

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

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.

Time frame
Baseline

Secondary outcomes

1

Proportion of patients independent

Proportion of patients independent is defined as the modified Rankin Scale score of 0, 1, or 2.

Time frame
90 days
2

National Institute of Health Stroke Scale

The National Institute of Health Stroke Scale (NIHSS) ranges from 0 to 42, with higher scores indicating more severe neurological deficits.

Time frame
Baseline, 7 days and 10 days after stroke onset.

Other outcomes

Sponsors and contacts

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