Clinical trial NCT05920902: Arterial Spin Label Depicted Ischemic Stroke Cohort (ASLIS)
Official title: Arterial Spin Label Depicted Ischemic Stroke Cohort (ASLIS)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Ischemic Stroke
Keywords: acute ischemia stroke, arterial spin labeling, evaluation
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2023-06-27
Enrollment: 200
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief summary: Establish a clinical cohort of acute ischemic stroke patients and find the determinant of the prognosis.

Detailed description: 1. Enrollment: screening the candidates based on the inclusion and exclusion criteria, and sign the informed consent.
2. Baseline evaluation: evaluate baseline situation of enrolled candidates.
3. Inpatient view: view and evaluate enrolled candidates respectively at day 1, 3, 7 and 14 after stroke, and record the results.
4. Follow-up: view the candidates at 90 days and one year after stroke onset, and record the results.
5. Data analysis: analyze the results.

Eligibility criteria: Inclusion Criteria:

1. Age 30-90, no gender restrictions.
2. Onset of disease ≤7 days.
3. 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).
4. Signed informed consent

Exclusion Criteria:

1. Clear cause of ischemic stroke other than atrial fibrillation.
2. Other ischemic strokes with a clear cause.
3. Presence of non-vascular intracranial disease.
4. Presence of severe systemic diseases.
5. Pregnancy or lactation.
6. Unable to tolerate or cooperate with MRI examination.
7. Unable to comply with follow-up due to geographical or other reasons.

Primary outcomes:
measure: Progressively deterioration in acute phase
timeFrame: 7 days after ischemia stroke onset
measure: Bad prognosis of acute ischemia stroke
timeFrame: 90 days after ischemia stroke onset
Secondary outcomes:
measure: Recurrent vascular episode
timeFrame: 1 year
measure: Recurrent artery stenosis
timeFrame: one year after stenting
measure: Unhealthy status
timeFrame: 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin hospital
state: Shanghai
Study officials:
affiliation: Ruijin Hospital
name: Wei Jin, PhD. MD.
role: PRINCIPAL_INVESTIGATOR
References: