Arterial Spin Label Depicted Ischemic Stroke Cohort (ASLIS)

NCT05920902 | Unknown DMC

• 1 other identifier: RJ_ASLIS
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Ischemic Stroke

Keywords

acute ischemia stroke, arterial spin labeling, evaluation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Recurrent vascular episode

  1 year

• Recurrent artery stenosis

  one year after stenting

• Unhealthy status

  1 year

Study Arms (1)

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

Interventions

routine therapy of acute ischemia stroke OTHER

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.

Acute ischemia stroke

Eligibility Criteria

• Age: 30 Years - 90 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age 30-90, no gender restrictions.
• Onset of disease ≤7 days.
• 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).
• Signed informed consent

You may not qualify if:

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

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin hospital

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Wei Jin, PhD. MD.

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Jin, PhD. MD.

CONTACT

18916705082; jw12170@rjh.com.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2023
• First Posted: June 27, 2023
• Study Start: October 1, 2021
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2024
• Last Updated: June 27, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)