NCT06047223

Brief Summary

This clinical study aims to confirm the characteristics of the functional ansiotropy value according to the individual characteristics of stroke patients by taking brain diffusion tensor images for stroke patients and using the MRI. To compare hematologic indicators and neurological function levels of stroke patients at the time of imaging examination with brain diffusion tensor imaging indicators.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

August 28, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
14 days until next milestone

Study Start

First participant enrolled

October 5, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

2.2 years

First QC Date

August 28, 2023

Last Update Submit

November 14, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Measurement of magnetic resonanace imaging (MRI)

    MRI scan is a process of measuring changes of diffusion tensor tractography

    Through study completion, an average of 1 day

Secondary Outcomes (18)

  • Measurement of Korean version of coma recovery scale-revised (K-CRSR)

    Through study completion, an average of 1 day

  • Measurement of Korean version of Montreal Cognitive Assessment (K-MoCA)

    Through study completion, an average of 1 day

  • Measurement of clinical dementia rate (CDR)

    Through study completion, an average of 1 day

  • Measurement of Korean version of oxford cognitive screen (OCS-K)

    visit 1

  • Measurement of digit span test.

    Through study completion, an average of 1 day

  • +13 more secondary outcomes

Interventions

Magnetic resonance imaging for measurement of diffustion tensor imaging

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Stroke patients

You may qualify if:

  • Adults aged 20 years or older with a history of stroke
  • After hearing a detailed explanation of this study and fully understanding it, the subject or legal representative voluntarily decides to participate and agrees in writing to observe the precautions

You may not qualify if:

  • Patients who meet one or more of the following cannot participate in the study.
  • Those with severe medical conditions such as unstable conditions in the cardiovascular system, digestive system, respiratory system, endocrine system, etc., and those with poor general health
  • In the case of a person with impaired consent, a person without a guardian
  • Patients who have devices that may be affected by MRI, such as pacemakers, spinal cord stimulators, cochlear implants, VP shunts, and nerve stimulators, inserted into the body
  • Other cases where the researcher judges that participation in this study is not suitable (This study is not an interventional study, and patients who are participating in other clinical trials or studies or who have participated in other clinical trials or studies within the past 30 days can also participate in this study.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHA Bundang Medical Center, CHA University

Seongnam-si, Gyeonggi-do, 463-712, South Korea

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Minyoung Kim, M.D., Ph.D.

    Bundang CHA Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

August 28, 2023

First Posted

September 21, 2023

Study Start

October 5, 2023

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

November 18, 2023

Record last verified: 2023-11

Locations