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

NCT05626296 | Recruiting

• 1 other identifier: 82102823-01
• Study Type: observational
• Target: 24
• 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)

• Omic biomarkers associated with phelm-heat syndrome in ischemic stroke

  Sensitivity, specificity, and area under the ROC curve of omic biomarkers of Phlegm-heat syndrome in ischemic stroke.

  baseline

Study Arms (3)

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

Healthy subjects

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Dongzhimen Hospital, Beijing: lead

Study Sites (1)

Dongzhimen Hospital

Beijing, Beijing Municipality, 100700, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Xinxing Lai

CONTACT

8615901111280; new-star@163.com

Study Design

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

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: November 23, 2022
• Study Start: November 14, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 20, 2024

Record last verified: 2024-06

Locations

CN (1)