Ischaemic StrokeNCT05922540
a Cohort Study of Ischemic Cerebrovascular Disease
An observational study of Ischaemic Stroke, run by Xiangya Hospital of Central South University at 1 site in China.
Trial summary
This study aims to establish a multicenter, large-scale, prospective cohort of patients with ischemic stroke. Various biological samples such as blood, feces, and urine are collected to identify biomarkers associated with ischemic stroke. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ischaemic Stroke
- What is being tested?
- Intravenous thrombolysis
- Type of treatment
- Injection or infusion
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2022to 1 Nov 2027
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Continuously enroll hospitalized patients who meet the inclusion criteria
Who may be able to join
- Clinical diagnosis of ischemic stroke.
- Age ≥ 18 years.
- Signed informed consent form.
Who cannot join
- Patients with moderate to severe mental disorders or dementia who cannot cooperate to complete the informed consent and follow-up procedures.
- Patients with neurological functional impairment caused by conditions such as migraine aura, epilepsy, or other non-ischemic strokes.
- Agitated patients who cannot cooperate with imaging examinations.
- Pregnant or lactating patients, as well as those planning to become pregnant within 90 days.
- Patients with concurrent malignant tumors or severe systemic diseases with an expected survival period of less than 90 days.
- Patients who have participated in other clinical studies within 30 days prior to enrollment or are currently participating in other interventional clinical studies.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xiangya Hospital, Central South University
Hunan, 410008
jian xia, MD, 13974880765, xjian1216@csu.edu.cn
About this study
Official title: a Prospective, Multicenter Cohort Study of Ischemic Cerebrovascular Disease
This study aims to establish a multicenter, large-scale, prospective cohort of patients with ischemic stroke. Various biological samples such as blood, feces, and urine are collected to identify biomarkers associated with ischemic stroke. By integrating demographic information, clinical indicators, imaging parameters, and biomarker parameters, the study aims to develop risk assessment, early warning, and prognosis prediction models. Additionally, the study aims to identify key genes and explore relevant signaling pathways related to ischemic stroke.
- Conditions
- Ischaemic Stroke
- Being tested
- Intravenous thrombolysis
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous thrombolysisOther
Intravenous thrombolysis with alteplase within the time window of stroke onset in stroke patients
| Study group | Role | What they receive |
|---|---|---|
| those with favorable prognosis | Not described Receives: Other: Intravenous thrombolysis | |
| those with unfavorable prognosis | Not described Receives: Other: Intravenous thrombolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebrovascular events
Cerebrovascular events, including ischemic stroke, transient ischemic attack, cerebral hemorrhage, subarachnoid hemorrhage
Measured: 3 months of onset in patients
mRS scores
Assessing patients' neurological functional impairment status using the mRS score
Measured: 3 months of onset in patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start1 Nov 2022
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischaemic StrokeStudies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- 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
- 5,000 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05922540
- Sponsor's protocol ID
- 202304068
- Status last verified
- Jun 2023
- First submitted
- 19 Jun 2023
- Last updated
- 28 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Privacy and Confidentiality: Sharing IPD may raise concerns regarding the privacy and confidentiality of the participants. Protecting the personal information and identities of the participants is a priority, and sharing IPD may involve potential risks in this regard.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- a Prospective, Multicenter Cohort Study of Ischemic Cerebrovascular Disease
- ClinicalTrials.gov ID
- NCT05922540
- Acronym / sponsor ID
- 202304068
- Conditions
- Ischaemic Stroke
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 28 Jun 2023 (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.
This study aims to establish a multicenter, large-scale, prospective cohort of patients with ischemic stroke. Various biological samples such as blood, feces, and urine are collected to identify biomarkers associated with ischemic stroke. By integrating demographic information, clinical indicators, imaging parameters, and biomarker parameters, the study aims to develop risk assessment, early warning, and prognosis prediction models. Additionally, the study aims to identify key genes and explore relevant signaling pathways related to ischemic stroke.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| those with favorable prognosis | – | Other: Intravenous thrombolysis |
| those with unfavorable prognosis | – | Other: Intravenous thrombolysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Continuously enroll hospitalized patients who meet the inclusion criteria
Key inclusion criteria (3 listed)
- Clinical diagnosis of ischemic stroke.
- Age ≥ 18 years.
- Signed informed consent form.
Key exclusion criteria (6 listed)
- Patients with moderate to severe mental disorders or dementia who cannot cooperate to complete the informed consent and follow-up procedures.
- Patients with neurological functional impairment caused by conditions such as migraine aura, epilepsy, or other non-ischemic strokes.
- Agitated patients who cannot cooperate with imaging examinations.
- Pregnant or lactating patients, as well as those planning to become pregnant within 90 days.
- Patients with concurrent malignant tumors or severe systemic diseases with an expected survival period of less than 90 days.
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 |
|---|---|---|
| Intravenous thrombolysisIntravenous thrombolysis with alteplase within the time window of stroke onset in stroke patients | Other | those with favorable prognosis, those with unfavorable prognosis |
Primary outcome
Cerebrovascular events
Time frame: 3 months of onset in patients
Cerebrovascular events, including ischemic stroke, transient ischemic attack, cerebral hemorrhage, subarachnoid hemorrhage
mRS scores
Time frame: 3 months of onset in patients
Assessing patients' neurological functional impairment status using the mRS score
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
- Individual participant dataSharing planned: No. Privacy and Confidentiality: Sharing IPD may raise concerns regarding the privacy and confidentiality of the participants. Protecting the personal information and identities of the participants is a priority, and sharing IPD may involve potential risks in this regard.
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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.
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 Ischaemic Stroke, run by Xiangya Hospital of Central South University 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 3 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 28 Jun 2023. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebrovascular events (time frame: 3 months of onset in patients). The study lists 2 primary outcomes in all. 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 28 Jun 2023.