Molecular Characteristics of Phlegm-heat Syndrome in Ischemic Stroke

NCT06470477 | Not Yet Recruiting

• 1 other identifier: 82102823-02
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke, Acute

Outcome Measures

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.

  Baseline

Secondary Outcomes (2)

• Proportion of patients independent

  90 days

• National Institute of Health Stroke Scale

  Baseline, 7 days and 10 days after stroke onset.

Study Arms (2)

Phlegm-heat syndrome

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.

Drug: Guideline-based treatment

Non-phlegm-heat syndrome

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.

Drug: Guideline-based treatment

Interventions

Guideline-based treatment DRUG

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

Also known as: Routine care

Non-phlegm-heat syndrome; Phlegm-heat syndrome

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Dongzhimen Hospital, Beijing: lead

Study Sites (1)

Dongzhimen Hospital

Beijing, Beijing Municipality, 100700, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral blood will be collected at admission.

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ying Gao, M.D.

  Dongzhimen Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xinxing Lai, M.D.

CONTACT

8615901111280; new-star@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: June 24, 2024
• Study Start: June 20, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 24, 2024

Record last verified: 2024-06

Locations

CN (1)