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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05920902
Other study ID # RJ_ASLIS
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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