Ischemic Stroke, AcuteNCT05626296
Molecular Network Characteristics of Phlegm-heat Syndrome in Ischemic Stroke Based on Multi-omics Integrated Analysis
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 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Ischemic Stroke, Acute
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 14 Nov 2022to 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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Dongzhimen Hospital
Beijing, Beijing Municipality, 100700
Xinxing Lai, M.D., 15901111280, new-star@163.com
About this 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 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
- Ischemic Stroke, Acute
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2022
- Study start14 Nov 2022
- 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
- Case-control
- Time perspective
- Other
- Enrolment
- 24 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05626296
- Sponsor's protocol ID
- 82102823-01
- Status last verified
- Jun 2024
- First submitted
- 14 Nov 2022
- Last updated
- 20 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Network Characteristics of Phlegm-heat Syndrome in Ischemic Stroke Based on Multi-omics Integrated Analysis
- ClinicalTrials.gov ID
- NCT05626296
- Acronym / sponsor ID
- 82102823-01
- Conditions
- Ischemic Stroke, Acute
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Dongzhimen Hospital, BeijingUniversity, hospital or other
- Study start
- 14 Nov 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 23 Nov 2022 (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 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 design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | – | – |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
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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.
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 20 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 (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?
Omic biomarkers associated with phelm-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 20 Jun 2024.