Molecular Characteristics of Phlegm-heat Syndrome in Ischemic Stroke

June 17, 2024 updated by: Ying Gao, Dongzhimen Hospital, Beijing

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

84

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100700
        • Dongzhimen Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Guideline-based treatment includes anti-platelet therapy, control of vascular risk factors, and so on.
Other Names:
  • Routine care
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
Guideline-based treatment includes anti-platelet therapy, control of vascular risk factors, and so on.
Other Names:
  • Routine care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity, specificity, and area under the ROC curve of molecular features of Phlegm-heat syndrome in ischemic stroke
Time Frame: 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.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients independent
Time Frame: 90 days
Proportion of patients independent is defined as the modified Rankin Scale score of 0, 1, or 2.
90 days
National Institute of Health Stroke Scale
Time Frame: 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.
Baseline, 7 days and 10 days after stroke onset.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dongzhimen Hospital, Beijing

Investigators

  • Principal Investigator: Ying Gao, M.D., Dongzhimen Hospital, Beijing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 20, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

November 14, 2022

First Submitted That Met QC Criteria

June 17, 2024

First Posted (Actual)

June 24, 2024

Study Record Updates

Last Update Posted (Actual)

June 24, 2024

Last Update Submitted That Met QC Criteria

June 17, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 82102823-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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