Ischemic Stroke, AcuteNCT06470477
Molecular Characteristics of Phlegm-heat Syndrome in Ischemic Stroke
An observational study of Ischemic Stroke, Acute, run by Dongzhimen Hospital, Beijing at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemic Stroke, Acute
- What is being tested?
- Guideline-based treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2024to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18 to 80 years with acute ischemic stroke within 72 hours of onset.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
China1 site
Dongzhimen Hospital
Beijing, Beijing Municipality, 100700
Xinxing Lai, M.D., 08615901111280, new-star@163.com
About this study
Official title: Molecular Characteristics of Phlegm-heat Syndrome in Ischemic Stroke: A Cohort Study
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.
Read the detailed description
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
- Ischemic Stroke, Acute
- Being tested
- Guideline-based treatment
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guideline-based treatmentDrug
Also called Routine care
Guideline-based treatment includes anti-platelet therapy, control of vascular risk factors, and so on.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Guideline-based treatment | |
| 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. Receives: Drug: Guideline-based treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity, specificity, and area under the ROC curve of molecular features of Phlegm-heat syndrome in ischemic stroke
Sensitivity, specificity, and area under the ROC curve of molecular features of Phlegm-heat syndrome in ischemic stroke.
The molecular characteristics of phlegm-heat syndrome in ischemic stroke include but are not limited to matrix metalloproteinase 9, mitogen-activated protein kinase 1, interleukin 6, and tumor necrosis factor.
Measured: Baseline
Secondary outcomes (2)
Proportion of patients independent
Proportion of patients independent is defined as the modified Rankin Scale score of 0, 1, or 2.
Measured: 90 days
National Institute of Health Stroke Scale
The National Institute of Health Stroke Scale (NIHSS) ranges from 0 to 42, with higher scores indicating more severe neurological deficits.
Measured: Baseline, 7 days and 10 days after stroke onset.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start20 Jun 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Stroke, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dongzhimen Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying Gao, Dongzhimen Hospital, Beijing
- Investigators
- Ying Gao, M.D., Principal investigator, Dongzhimen Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06470477
- Sponsor's protocol ID
- 82102823-02
- Status last verified
- Jun 2024
- First submitted
- 14 Nov 2022
- Last updated
- 24 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Characteristics of Phlegm-heat Syndrome in Ischemic Stroke: A Cohort Study
- ClinicalTrials.gov ID
- NCT06470477
- Acronym / sponsor ID
- 82102823-02
- Conditions
- Ischemic Stroke, Acute
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Dongzhimen Hospital, BeijingUniversity, hospital or other
- Study start
- 20 Jun 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 24 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phlegm-heat syndrome | – | Drug: Guideline-based treatmentPhlegm-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. |
| Non-phlegm-heat syndrome | – | Drug: Guideline-based treatmentNon-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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 to 80 years with acute ischemic stroke within 72 hours of onset.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guideline-based treatmentAlso: Routine careGuideline-based treatment includes anti-platelet therapy, control of vascular risk factors, and so on. | Drug | Non-phlegm-heat syndrome, Phlegm-heat syndrome |
Primary outcome
Sensitivity, specificity, and area under the ROC curve of molecular features of Phlegm-heat syndrome in ischemic stroke
Time frame: Baseline
Sensitivity, specificity, and area under the ROC curve of molecular features of Phlegm-heat syndrome in ischemic stroke. The molecular characteristics of phlegm-heat syndrome in ischemic stroke include but are not limited to matrix metalloproteinase 9, mitogen-activated protein kinase 1, interleukin 6, and tumor necrosis factor.
2 secondary outcomes
Proportion of patients independent
Time frame: 90 days
National Institute of Health Stroke Scale
Time frame: Baseline, 7 days and 10 days after stroke onset.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ying Gao, M.D. principal investigator
Dongzhimen Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, Acute, run by Dongzhimen Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xinxing Lai, M.D. (8615901111280, new-star@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity, specificity, and area under the ROC curve of molecular features of Phlegm-heat syndrome in ischemic stroke (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2024.