Acute Ischemic StrokeASLISNCT05920902
Arterial Spin Label Depicted Ischemic Stroke Cohort (ASLIS)
An observational study of Acute Ischemic Stroke, run by Ruijin Hospital at 1 site in China.
Trial summary
Establish a clinical cohort of acute ischemic stroke patients and find the determinant of the prognosis. Read more about this study
- Who is it for?
- Ages 30 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- routine therapy of acute ischemia stroke
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2021to 31 Dec 2024
- How long will I take part?
- 1 Year
- 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 30 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Who sufferred acute ischemia stroke and be admitted to the ward of Ruijin Hospital, and meets the inclusion criteria, and does not meet the exclusion criteria.
Who may be able to join
- Age 30-90, no gender restrictions.
- Onset of disease ≤7 days.
- Meet either of the following two conditions:
- ① Transient ischemic attack (TIA)
- ② Ischemia stroke (IS) Note: Acute IS diagnosis criteria: sudden and persistent focal or widespread neurological dysfunction, excluding other non-vascular causes of brain dysfunction (such as brain infection, head injury, brain tumor, epilepsy, severe metabolic diseases, or degenerative neurological diseases), confirmed by image as new IS. TIA diagnosis criteria: sudden and reversible focal neurological or retinal ischemic deficit caused by a reversible ischemia, usually lasting less than 24 hours, with no evidence of new IS on imaging, and excluding other non-ischemic causes (such as brain infection, head injury, brain tumor, epilepsy, severe metabolic diseases, or degenerative neurological diseases).
- Signed informed consent
Who cannot join
- Clear cause of ischemic stroke other than atrial fibrillation.
- Other ischemic strokes with a clear cause.
- Presence of non-vascular intracranial disease.
- Presence of severe systemic diseases.
- Pregnancy or lactation.
- Unable to tolerate or cooperate with MRI examination.
- Unable to comply with follow-up due to geographical or other reasons.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ruijin hospital
Shanghai, Shanghai Municipality, 200000
About this study
Establish a clinical cohort of acute ischemic stroke patients and find the determinant of the prognosis.
Read the detailed description
- Enrollment: screening the candidates based on the inclusion and exclusion criteria, and sign the informed consent.
- Baseline evaluation: evaluate baseline situation of enrolled candidates.
- Inpatient view: view and evaluate enrolled candidates respectively at day 1, 3, 7 and 14 after stroke, and record the results.
- Follow-up: view the candidates at 90 days and one year after stroke onset, and record the results.
- Data analysis: analyze the results.
- Conditions
- Acute Ischemic Stroke
- Being tested
- routine therapy of acute ischemia stroke
- Keywords
- acute ischemia stroke, arterial spin labeling, evaluation
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
routine therapy of acute ischemia strokeOther
Routine therapy of acute ischemia stroke based on the guidelines, which generally includes two parts: evaluation and medicine treatment. Evaluation includes peripheral blood test, radiologic examination, electrophysiological examination, ultrasonic examination. Medicine treatment includes drug therapy and rehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| Acute ischemia stroke | Best medcine treatment. It including antiplatelet drugs, statins, hypotensive drugs, antidiabetics, neurotrophic drugs, butylphthalide, edaravone. Receives: Other: routine therapy of acute ischemia stroke |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progressively deterioration in acute phase
Number of participants whose SNOB (Standardised nursing observations for stroke) score at 7 days post ischemia stroke ≤ 2 points compared to baseline, and/or NIHSS score at 7 days post ischemia stroke ≥ 2 points compared to baseline are identified as progressively deterioration in acute phase.
Measured: 7 days after ischemia stroke onset
Bad prognosis of acute ischemia stroke
Number of participants whose mRS (Modified rankin scale) score at 90 days after ischemia > 2 are identified as bad prognosis.
Measured: 90 days after ischemia stroke onset
Secondary outcomes (3)
Recurrent vascular episode
Including transient ischemia attack, intracranial hemorrhage, ischemia stroke
Measured: 1 year
Recurrent artery stenosis
Degree of artery stenosis at one year after stenting > 50%
Measured: one year after stenting
Unhealthy status
Any dimension in EQ-5D-3L (the generic three-level EuroQol five-dimensional questionnaire) score ≥ 2
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start1 Oct 2021
- Primary completion30 Jun 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 Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Ruijin 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei Jin, PhD. MD., Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05920902
- Sponsor's protocol ID
- RJ_ASLIS
- Acronym
- ASLIS
- Status last verified
- Feb 2023
- First submitted
- 9 Feb 2023
- Last updated
- 27 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Results of the research will be shared in the form of paper publishing. Other researchers who wants to know the details can contact with the PI.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arterial Spin Label Depicted Ischemic Stroke Cohort (ASLIS)
- ClinicalTrials.gov ID
- NCT05920902
- Acronym / sponsor ID
- ASLIS / RJ_ASLIS
- Conditions
- Acute Ischemic Stroke
- Keywords
- acute ischemia stroke, arterial spin labeling, evaluation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 27 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.
Establish a clinical cohort of acute ischemic stroke patients and find the determinant of the prognosis.
Detailed description
- Enrollment: screening the candidates based on the inclusion and exclusion criteria, and sign the informed consent.
- Baseline evaluation: evaluate baseline situation of enrolled candidates.
- Inpatient view: view and evaluate enrolled candidates respectively at day 1, 3, 7 and 14 after stroke, and record the results.
- Follow-up: view the candidates at 90 days and one year after stroke onset, and record the results.
- Data analysis: analyze the results.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute ischemia stroke | – | Other: routine therapy of acute ischemia strokeBest medcine treatment. It including antiplatelet drugs, statins, hypotensive drugs, antidiabetics, neurotrophic drugs, butylphthalide, edaravone. |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Who sufferred acute ischemia stroke and be admitted to the ward of Ruijin Hospital, and meets the inclusion criteria, and does not meet the exclusion criteria.
Key inclusion criteria (6 listed)
- Age 30-90, no gender restrictions.
- Onset of disease ≤7 days.
- Meet either of the following two conditions:
- ① Transient ischemic attack (TIA)
- ② Ischemia stroke (IS) Note: Acute IS diagnosis criteria: sudden and persistent focal or widespread neurological dysfunction, excluding other non-vascular causes of brain dysfunction (such as brain infection, head injury, brain tumor, epilepsy, severe metabolic diseases, or degenerative neurological diseases), confirmed by image as new IS. TIA diagnosis criteria: sudden and reversible focal neurological or retinal ischemic deficit caused by a reversible ischemia, usually lasting less than 24 hours, with no evidence of new IS on imaging, and excluding other non-ischemic causes (such as brain infection, head injury, brain tumor, epilepsy, severe metabolic diseases, or degenerative neurological diseases).
Key exclusion criteria (7 listed)
- Clear cause of ischemic stroke other than atrial fibrillation.
- Other ischemic strokes with a clear cause.
- Presence of non-vascular intracranial disease.
- Presence of severe systemic diseases.
- Pregnancy or lactation.
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 |
|---|---|---|
| routine therapy of acute ischemia strokeRoutine therapy of acute ischemia stroke based on the guidelines, which generally includes two parts: evaluation and medicine treatment. Evaluation includes peripheral blood test, radiologic examination, electrophysiological examination, ultrasonic examination. Medicine treatment includes drug therapy and rehabilitation. | Other | Acute ischemia stroke |
Primary outcome
Progressively deterioration in acute phase
Time frame: 7 days after ischemia stroke onset
Number of participants whose SNOB (Standardised nursing observations for stroke) score at 7 days post ischemia stroke ≤ 2 points compared to baseline, and/or NIHSS score at 7 days post ischemia stroke ≥ 2 points compared to baseline are identified as progressively deterioration in acute phase.
Bad prognosis of acute ischemia stroke
Time frame: 90 days after ischemia stroke onset
Number of participants whose mRS (Modified rankin scale) score at 90 days after ischemia > 2 are identified as bad prognosis.
3 secondary outcomes
Recurrent vascular episode
Time frame: 1 year
Recurrent artery stenosis
Time frame: one year after stenting
Unhealthy status
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- Individual participant dataSharing planned: No. Results of the research will be shared in the form of paper publishing. Other researchers who wants to know the details can contact with the PI.
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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.
Wei Jin, PhD. MD. principal investigator
Ruijin Hospital
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 Acute Ischemic Stroke, run by Ruijin Hospital 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 6 inclusion and 7 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 27 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Jin, PhD. MD. (18916705082, jw12170@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progressively deterioration in acute phase (time frame: 7 days after ischemia stroke onset). 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 27 Jun 2023.