Arterial Spin Label Depicted Ischemic Stroke Cohort (ASLIS)

Acute Ischemic Stroke Clinical Trial

— ASLIS  

Official title:

Arterial Spin Label Depicted Ischemic Stroke Cohort (ASLIS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05920902
• Other study ID #: RJ_ASLIS
• Status: Recruiting
• Start date: October 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2023
• Source: Ruijin Hospital
• Contact: Wei Jin, PhD. MD.
• Phone: 18916705082
• Email: jw12170[@]rjh.com.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Age 30-90, no gender restrictions.

2. Onset of disease =7 days.

3. Meet either of the following two conditions:

? Transient ischemic attack (TIA)

? 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.

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Other:
• routine therapy of acute ischemia stroke
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.

Locations

Country	Name	City	State
China	Ruijin hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	7 days after ischemia stroke onset
Primary	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.	90 days after ischemia stroke onset
Secondary	Recurrent vascular episode	Including transient ischemia attack, intracranial hemorrhage, ischemia stroke	1 year
Secondary	Recurrent artery stenosis	Degree of artery stenosis at one year after stenting > 50%	one year after stenting
Secondary	Unhealthy status	Any dimension in EQ-5D-3L (the generic three-level EuroQol five-dimensional questionnaire) score = 2	1 year