Ischemic StrokeNCT02756494
Ischemic Stroke in Chinese Young Adults
An observational study of Ischemic Stroke, run by Beijing Chao Yang Hospital.
Trial summary
Stroke is the fifth leading cause of death in the United States and the leading cause of disability. However, in China, stroke is one of the most frequent causes of death and chronic disability. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Ischemic Stroke
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Dec 2018
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients between 18 and 45 years of age with a first ever ischaemic stroke are eligible for this study from the Department of Beijing Chaoyang Hospital between January 1, 2016 and December 31, 2016. All patients were defined as a sudden loss of global or focal cerebral function that persisted with a probable vascular cause for 24h and confirmed by brain CT or MRI.
Who may be able to join
- Patients between 18 and 45 years of age with a first ever ischaemic stroke are eligible for this study from the Department of Beijing Chaoyang Hospital between January 1, 2016 and December 31, 2016.
- All patients were defined as a sudden loss of global or focal cerebral function that persisted with a probable vascular cause for 24h and confirmed by brain CT or MRI.
Who cannot join
- The exclusion criteria will include patients with intracranial lesions or cerebrovascular disease (including cerebral venous sinus thrombosis)
- History that have caused sequelae, such as movement disorders, mood disorders, cognitive dysfunction or speech problems; or individuals who are pregnant or breast feeding.
- Patients with serious diseases that are related to the heart, liver, kidney or haematopoietic system will not be allowed to participate.
About this study
Official title: Some Biomarkers Underlying in Ischemic Stroke in Chinese Young Adults: a Protocol for a Case-control Clinical Trial
Stroke is the fifth leading cause of death in the United States and the leading cause of disability. However, in China, stroke is one of the most frequent causes of death and chronic disability. Ischemic strokes in adults younger than 45 years of age were regarded as a relatively uncommon event in the proportion of <5% of all ischemic strokes.
Read the detailed description
Currently, stroke is the fifth leading cause of death in the United States and the leading cause of disability. However, in China, stroke is one of the most frequent causes of death and chronic disability. Ischemic strokes in adults younger than 45 years of age were regarded as a relatively uncommon event in the proportion of <5% of all ischemic strokes. Our study aimed to evaluate some Biomarkers Underlying in Ischemic Stroke in Chinese Young Adults.
- Conditions
- Ischemic Stroke
- Being tested
- Ischemic Stroke
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ischemic StrokeBiological
Ischemic Stroke in Chinese Young Adults
| Study group | Role | What they receive |
|---|---|---|
| Ischemic Stroke in Young Adults | Patients between 18 and 45 years of age with a first ever ischaemic stroke are eligible for this study from the Department of Beijing Chaoyang Hospital between January 1, 2016 and December 31, 2016. All patients were defined as a sudden loss of global or focal cerebral function that persisted with a probable vascular cause for 24h and confirmed by brain CT or MRI. Receives: Biological: Ischemic Stroke | |
| matched control subjects | The age-, sex-, and time of enrollment-matched control cohort was randomly identified after eliminating the study subjects and those who had been given a diagnosis of any stroke at any time. Receives: Biological: Ischemic Stroke |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of Ischemic Stroke in Chinese Young Adults
the incidence of Ischemic Stroke
Measured: every two months, up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionApr 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Beijing Chao Yang HospitalThe 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guang Wang, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02756494
- Sponsor's protocol ID
- Ischemic201603
- Status last verified
- Apr 2016
- First submitted
- 3 Apr 2016
- Last updated
- 29 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Some Biomarkers Underlying in Ischemic Stroke in Chinese Young Adults: a Protocol for a Case-control Clinical Trial
- ClinicalTrials.gov ID
- NCT02756494
- Acronym / sponsor ID
- Ischemic201603
- Conditions
- Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 29 Apr 2016 (estimated)
- 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.
Stroke is the fifth leading cause of death in the United States and the leading cause of disability. However, in China, stroke is one of the most frequent causes of death and chronic disability. Ischemic strokes in adults younger than 45 years of age were regarded as a relatively uncommon event in the proportion of <5% of all ischemic strokes.
Detailed description
Currently, stroke is the fifth leading cause of death in the United States and the leading cause of disability. However, in China, stroke is one of the most frequent causes of death and chronic disability. Ischemic strokes in adults younger than 45 years of age were regarded as a relatively uncommon event in the proportion of <5% of all ischemic strokes. Our study aimed to evaluate some Biomarkers Underlying in Ischemic Stroke in Chinese Young Adults.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ischemic Stroke in Young Adults | – | Biological: Ischemic StrokePatients between 18 and 45 years of age with a first ever ischaemic stroke are eligible for this study from the Department of Beijing Chaoyang Hospital between January 1, 2016 and December 31, 2016. All patients were defined as a sudden loss of global or focal cerebral function that persisted with a probable vascular cause for 24h and confirmed by brain CT or MRI. |
| matched control subjects | – | Biological: Ischemic StrokeThe age-, sex-, and time of enrollment-matched control cohort was randomly identified after eliminating the study subjects and those who had been given a diagnosis of any stroke at any time. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients between 18 and 45 years of age with a first ever ischaemic stroke are eligible for this study from the Department of Beijing Chaoyang Hospital between January 1, 2016 and December 31, 2016. All patients were defined as a sudden loss of global or focal cerebral function that persisted with a probable vascular cause for 24h and confirmed by brain CT or MRI.
Key inclusion criteria (2 listed)
- Patients between 18 and 45 years of age with a first ever ischaemic stroke are eligible for this study from the Department of Beijing Chaoyang Hospital between January 1, 2016 and December 31, 2016.
- All patients were defined as a sudden loss of global or focal cerebral function that persisted with a probable vascular cause for 24h and confirmed by brain CT or MRI.
Key exclusion criteria (3 listed)
- The exclusion criteria will include patients with intracranial lesions or cerebrovascular disease (including cerebral venous sinus thrombosis)
- History that have caused sequelae, such as movement disorders, mood disorders, cognitive dysfunction or speech problems; or individuals who are pregnant or breast feeding.
- Patients with serious diseases that are related to the heart, liver, kidney or haematopoietic system will not be allowed to participate.
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 |
|---|---|---|
| Ischemic StrokeIschemic Stroke in Chinese Young Adults | Biological | Ischemic Stroke in Young Adults, matched control subjects |
Primary outcome
the incidence of Ischemic Stroke in Chinese Young Adults
Time frame: every two months, up to 24 months
the incidence of Ischemic Stroke
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2016.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, run by Beijing Chao Yang Hospital.
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 2 inclusion and 3 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 29 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of Ischemic Stroke in Chinese Young Adults (time frame: every two months, up to 24 months). 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 29 Apr 2016.