- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05626296
Molecular Network Characteristics of Phlegm-heat Syndrome in Ischemic Stroke Based on Multi-omics Integrated Analysis
March 24, 2023 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 (Anticipated)
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
- Name: Xinxing Lai
- Phone Number: 8615901111280
- Email: new-star@163.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100700
- Recruiting
- Dongzhimen Hospital
-
Contact:
- Xinxing Lai, M.D.
- Phone Number: 15901111280
- Email: new-star@163.com
-
-
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
Genders Eligible for Study
All
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
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 (Anticipated)
June 30, 2023
Study Completion (Anticipated)
December 31, 2023
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)
March 27, 2023
Last Update Submitted That Met QC Criteria
March 24, 2023
Last Verified
March 1, 2023
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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