Molecular Network Characteristics of Phlegm-heat Syndrome in Ischemic Stroke Based on Multi-omics Integrated Analysis

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

Recruiting

Conditions

Detailed Description

This is a cohort study in patients with ischemic stroke. The demographic characteristics, 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)

24

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
        • Recruiting
        • 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

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients aged 50 to 80 years with acute ischemic stroke within 72 hours of onset. Moreover, these patients fit the diagnosis of phlegm-heat syndrome or non-phlegm-heat syndrome.

Description

Inclusion Criteria:

  • Acute ischemic stroke, were confirmed by magnetic resonance imaging (MRI).
  • Symptom onset within 72 hours.
  • Diagnosis of phlegm-heat syndrome or non-phlegm-heat syndrome.
  • Male or female ≥ 50 years and ≤ 80 years.
  • With written informed consent.

Exclusion Criteria:

  • Planned or already receiving intravenous thrombolysis or endovascular treatment.
  • Acute infectious diseases or acute exacerbations of chronic diseases within one month before enrollment.
  • Patients with previous stroke.
  • Renal or hepatic insufficiency, tumors, immune diseases, severe underlying diseases.
  • Other conditions that may 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

  • Observational Models: Case-Control
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Healthy subjects
Phlegm-heat syndrome in ischemic stroke
Phlegm-heat syndrome: the score of "Phlegm-dampness syndrome" ≥10 with the score of "Internal fire syndrome" ≥10 in Diagnostic Scale for Syndrome Elements of Ischemic Stroke
Non-phlegm-heat syndrome in ischemic stroke
Non-phlegm-heat syndrome: the score of "Phlegm-dampness syndrome" <10 with the score of "Internal fire syndrome" <10 in Diagnostic Scale for Syndrome Elements of Ischemic Stroke

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Omic biomarkers associated with phelm-heat syndrome in ischemic stroke
Time Frame: baseline
Sensitivity, specificity, and area under the ROC curve of omic biomarkers of Phlegm-heat syndrome in ischemic stroke.
baseline

Collaborators and Investigators

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

Sponsor

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 (Actual)

November 14, 2022

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

November 19, 2022

First Posted (Actual)

November 23, 2022

Study Record Updates

Last Update Posted (Actual)

June 20, 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

  • 82102823-01

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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