Molecular Characteristics of Phlegm-heat Syndrome in Ischemic Stroke

NCT ID: NCT06470477

Last Updated: 2024-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

84 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-20

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Ischemic Stroke, Acute

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Guideline-based treatment

Intervention Type DRUG

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

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.

Guideline-based treatment

Intervention Type DRUG

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

Interventions

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Guideline-based treatment

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

Intervention Type DRUG

Other Intervention Names

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Routine care

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dongzhimen Hospital, Beijing

OTHER

Sponsor Role lead

Responsible Party

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Ying Gao

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ying Gao, M.D.

Role: PRINCIPAL_INVESTIGATOR

Dongzhimen Hospital, Beijing

Locations

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Dongzhimen Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Central Contacts

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Xinxing Lai, M.D.

Role: CONTACT

8615901111280

Facility Contacts

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Xinxing Lai, M.D.

Role: primary

08615901111280

Other Identifiers

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82102823-02

Identifier Type: -

Identifier Source: org_study_id

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