Arterial Spin Label Depicted Ischemic Stroke Cohort (ASLIS)

Recruiting

• Conditions: Acute Ischemic Stroke
• Interventions: Other: routine therapy of acute ischemia stroke

• Registration Number: NCT05920902
• Lead Sponsor: Ruijin Hospital

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.

Study Timeline

• Study Start: 2021-10-01
• Status Verified: 2023-02
• Study First Submitted: 2023-02-09
• Study First Submitted QC: 2023-06-24
• Last Update Submitted: 2023-06-24
• Study First Posted: 2023-06-27
• Last Update Posted: 2023-06-27
• Primary Completion: 2024-06-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Acute ischemia stroke	routine therapy of acute ischemia stroke	Best medcine treatment. It including antiplatelet drugs, statins, hypotensive drugs, antidiabetics, neurotrophic drugs, butylphthalide, edaravone.

Primary Outcome Measures

Name	Time	Method
Progressively deterioration in acute phase	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	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.

Secondary Outcome Measures

Name	Time	Method
Recurrent vascular episode	1 year	Including transient ischemia attack, intracranial hemorrhage, ischemia stroke
Recurrent artery stenosis	one year after stenting	Degree of artery stenosis at one year after stenting \> 50%
Unhealthy status	1 year	Any dimension in EQ-5D-3L (the generic three-level EuroQol five-dimensional questionnaire) score ≥ 2

Trial Locations

Locations (1)

Ruijin hospital; 🇨🇳 Shanghai, Shanghai, China