Molecular Characteristics of Phlegm-heat Syndrome in Ischemic Stroke

Dongzhimen Hospital, Beijing

Status: Not yet enrolling

Conditions: Ischemic Stroke, Acute

Treatments: Drug: Guideline-based treatment

Study type: Observational

Funder types: Other

Identifiers

NCT06470477

82102823-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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).

Trial design

84 participants in 2 patient groups

Phlegm-heat syndrome

Description:

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.

Treatment:

Drug: Guideline-based treatment

Non-phlegm-heat syndrome

Description:

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.

Treatment:

Drug: Guideline-based treatment