Non-disabling Ischemic Cerebrovascular Event With Apathy
1 other identifier
observational
200
1 country
1
Brief Summary
The burden of non-disabling ischemic cerebrovascular events (NICE) is significantly increased. However, few previous studies have focused on affective impairment after transient ischemic attack (TIA) and minor stroke. Stroke survivors are often described as apathetic. Even though post-stroke apathy (PSA) affects one in three stroke patients,it has not hitherto received much attention. NICE-A is a prospective study aimed to explore the association between baseline apathy and probable incident stroke in a population-based sample of TIA and minor stroke adults.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 2, 2021
CompletedFirst Posted
Study publicly available on registry
June 8, 2021
CompletedStudy Start
First participant enrolled
July 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 10, 2024
CompletedFebruary 13, 2024
February 1, 2024
2.9 years
June 2, 2021
February 11, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
Death
Death from any cause
1 month
Death
Death from any cause
3 months
Death
Death from any cause
6 months
Death
Death from any cause
12 months
Stroke recurrence
Ischemic stroke
1 month
Stroke recurrence
Ischemic stroke
3 months
Stroke recurrence
Ischemic stroke
6 months
Stroke recurrence
Ischemic stroke
12 months
Secondary Outcomes (8)
Hemorrhagic stroke
1 month
Hemorrhagic stroke
3 months
Hemorrhagic stroke
6 months
Hemorrhagic stroke
12 months
Functional outcome
1 month
- +3 more secondary outcomes
Eligibility Criteria
Adults patients (≥18 years) within 1 month of onset of a minor stroke (National Institute of Health stroke scale, NIHSS≤3) and TIA.
You may qualify if:
- ≥18 years old Onset of a minor stroke (National Institute of Health stroke scale, NIHSS≤3) and TIA elapsed time from last episode to registry \<1 month
You may not qualify if:
- patients who refused to participate in the research, and patients who failed to complete the follow-up protocol.
- patients with malignant tumors, or patients with severe liver or kidney disease, whose life expectancy is less than 1 year.
- patients who received endovascular or thrombolytic therapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Changhai Hospital
Shanghai, Shanghai Municipality, 200433, China
Biospecimen
blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiaoying Bi, MD, PhD
Department of Changhai Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 2, 2021
First Posted
June 8, 2021
Study Start
July 10, 2021
Primary Completion
June 1, 2024
Study Completion
June 10, 2024
Last Updated
February 13, 2024
Record last verified: 2024-02