Taiwan Post-Stroke Disability Study

NCT06772194 | Recruiting DMC

• 1 other identifier: 202408111RIPC
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke remains a major health issue in Taiwan, being the fourth leading cause of death and the top cause of disability. While past research has focused on functional outcomes at three months post-stroke, stroke can cause a range of disabilities in areas such as motor function, swallowing, cognition, depression, and epilepsy. This study will investigate these disabilities by enrolling 2,000 acute stroke patients (both ischemic and hemorrhagic) from 10 medical centers across Taiwan. Data will be collected at three key points: at enrollment, three months, and twelve months post-stroke, using surveys, assessments, imaging, and blood samples. The aim is to examine the prevalence, risk factors, and long-term changes of post-stroke disabilities, ultimately seeking ways to reduce the health burden of stroke in Taiwan.

Conditions

Stroke; Dementia; Epilepsy; Depression

Keywords

post stroke care; Stroke; Dementia; Epilepsy; Acute stroke; swallowing; vascular dementia; cognition impairment; depression; Gait

Outcome Measures

Primary Outcomes (1)

• Number of patients with recurrent stroke, including ischemic and hemorrhagic stroke

  Any clinically identified stroke after the index stroke event between baseline and 3 months, or between 3 and 12 months

  3 & 12 month

Secondary Outcomes (2)

• Changes in the modified Rankin Scale (mRS) score at 3 & 12 months

  3 & 12 month

• Changes in the National Institutes of Health Stroke Scale (NIHSS) score at 3 & 12 months

  3 & 12 month

Other Outcomes (4)

• Number of patients with Major Cardiovascular Events (MACE)

  3 & 12 month

• Death

  3 & 12 month

• Hospitalization due to aspiration pneumonia

  3 & 12 month

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will screen patients after a confirmed diagnosis of acute stroke. Enrollment will primarily occur during the patient's acute-phase hospitalization but may also take place during outpatient follow-up visits after discharge. Enrollment will not be conducted in the emergency department and will primarily occur within one month of stroke onset.

You may qualify if:

• Ischemic stroke confirmed by MRI, or hemorrhagic stroke diagnosed by CT or MRI.
• Age ≥ 18 years.
• Pre-stroke modified Rankin Scale (mRS) score of 0, 1, or 2.
• Post-stroke mRS score of 0, 1, 2, 3, or 4 at enrollment.
• Able to undergo cognitive function screening and other scale assessments within 30 days post-stroke.

You may not qualify if:

• Transient ischemic stroke and subarachnoid hemorrhage.
• Clear and severe psychiatric or emotional disorders before the stroke, including schizophrenia, major depressive disorder, and bipolar disorder.
• History of clinical stroke within three months prior to enrollment.
• Unable to communicate or cooperate for assessments due to severe aphasia.
• Severe dementia prior to the stroke.
• Pre-stroke modified Rankin Scale (mRS) score ≥ 3.
• Post-stroke mRS score of 5 at enrollment.
• History of cancer with an expected life expectancy of less than one year.
• Expected life expectancy of less than one year due to other medical conditions.
• Anticipated inability to complete a one-year follow-up.
• Other situations deemed unsuitable for enrollment by the clinical investigator.

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• National Taiwan University Hospital Hsin-Chu Branch: collaborator
• National Taiwan University Hospital, Yun-Lin Branch: collaborator
• Shin Kong Wu Ho-Su Memorial Hospital: collaborator
• Mackay Memorial Hospital: collaborator
• Chang Gung Memorial Hospital: collaborator
• National Cheng Kung University: collaborator
• Landseed Hospital: collaborator
• Taichung Veterans General Hospital: collaborator
• Taipei Veterans General Hospital, Taiwan: collaborator
• Tri-Service General Hospital: collaborator
• AbbVie: collaborator
• Taipei Medical University Shuang Ho Hospital: collaborator
• Chi Mei Medical Hospital: collaborator
• Chang Gung Memorial Hospital, Keelung: collaborator

Study Sites (1)

National Taiwan University Hospital, Taipei,

Taipei, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

A 10 mL purple-top tube (containing EDTA) of blood will be collected during the patient's routine blood draw. After centrifugation, the sample will be separated into buffy coat and plasma, which will be stored at -80°C. The processed blood samples will then be sent to Professor Hung-Yi Chiu's laboratory at the National Health Research Institutes for genomic (GWAS) and proteomics studies.

MeSH Terms

Conditions

Stroke; Dementia; Epilepsy; Depression; Dementia, Vascular

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases

Central Study Contacts

Chih-Hao Chen, Dotoral

CONTACT

+886-2-2312-3456; antonyneuro@gmail.com

Jiann-Shing Jeng, PhD

CONTACT

+886-2-23123456; jsjeng@ntu.edu.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 2, 2025
• First Posted: January 13, 2025
• Study Start: October 21, 2024
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: May 13, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)