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

NCT ID: NCT05626296

Last Updated: 2024-06-20

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

RECRUITING

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-14

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 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.

Conditions

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Ischemic Stroke, Acute

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Study Groups

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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

No interventions assigned to this group

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

No interventions assigned to this group

Healthy subjects

No interventions assigned to this group

Eligibility Criteria

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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).
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

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

Locations

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Dongzhimen Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xinxing Lai

Role: CONTACT

8615901111280

Facility Contacts

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Xinxing Lai, M.D.

Role: primary

15901111280

Other Identifiers

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82102823-01

Identifier Type: -

Identifier Source: org_study_id

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