Arterial Spin Label Depicted Ischemic Stroke Cohort (ASLIS) (ASLIS)

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

Study Overview

• Status: Recruiting
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Wei Jin, PhD. MD.; Phone Number: 18916705082; Email: jw12170@rjh.com.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Recruiting
      • Ruijin Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: February 9, 2023
• First Submitted That Met QC Criteria: June 24, 2023
• First Posted (Actual): June 27, 2023

Study Record Updates

• Last Update Posted (Actual): June 27, 2023
• Last Update Submitted That Met QC Criteria: June 24, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: acute ischemia stroke, arterial spin labeling, evaluation
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Cerebral Infarction
• Other Study ID Numbers: RJ_ASLIS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No