Arterial Spin Label Depicted Ischemic Stroke Cohort (ASLIS)

• Sponsor: Ruijin Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05920902
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Anticipated Duration (Months): 39
• Patients Per Site Per Month: 5.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Acute Ischemic Stroke	Other: routine therapy of acute ischemia stroke

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 Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 200 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Arterial Spin Label Depicted Ischemic Stroke Cohort (ASLIS)
• Actual Study Start Date: Oct 1, 2021
• Anticipated Primary Completion Date: Jun 30, 2024
• Anticipated Study Completion Date: Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Acute ischemia stroke Best medcine treatment. It including antiplatelet drugs, statins, hypotensive drugs, antidiabetics, neurotrophic drugs, butylphthalide, edaravone.	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.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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

1. Recurrent vascular episode [1 year]

   Including transient ischemia attack, intracranial hemorrhage, ischemia stroke

2. Recurrent artery stenosis [one year after stenting]

   Degree of artery stenosis at one year after stenting > 50%

3. Unhealthy status [1 year]

   Any dimension in EQ-5D-3L (the generic three-level EuroQol five-dimensional questionnaire) score ≥ 2

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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).

1. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ruijin hospital	Shanghai	Shanghai	China	200000

Sponsors and Collaborators

• Ruijin Hospital

Investigators

• Principal Investigator: Wei Jin, PhD. MD., Ruijin Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ruijin Hospital
• ClinicalTrials.gov Identifier: NCT05920902
• Other Study ID Numbers: RJ_ASLIS
• First Posted: Jun 27, 2023
• Last Update Posted: Jun 27, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ruijin Hospital: acute ischemia stroke, arterial spin labeling, evaluation
• Additional relevant MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia

Study Results

No Results Posted as of Jun 27, 2023