Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
MRI-DTI as a Predictor of Functional Outcome in Acute Ischemic Stroke
This study is currently recruiting participants.
Verified by Taipei Municipal Wan Fang Hospital, June 2008
Sponsored by: Taipei Municipal Wan Fang Hospital
Information provided by: Taipei Municipal Wan Fang Hospital
ClinicalTrials.gov Identifier: NCT00696306
  Purpose

The purpose of the study is to use diffusion tensor imaging (DTI) derived axial diffusivity to evaluate the severity of acute ischemic stroke and to predict its functional outcome.


Condition
Acute Ischemic Stroke
Stroke
Cerebral Stroke
Cerebrovascular Accident

U.S. FDA Resources
Study Type: Observational
Study Design: Case-Only, Prospective
Official Title: Diffusion Tensor Imaging (DTI) Derived Axial Diffusivity as a Predictor of Functional Outcome in Acute Ischemic Stroke

Further study details as provided by Taipei Municipal Wan Fang Hospital:

Primary Outcome Measures:
  • To correlate the prognosis of acute ischemic stroke with the result of MRI-DTI. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To establish the DTI protocol as the biomarker for future research in neurological disorders, such as brain tumor, brain injury, brain developmental disorders, and Multiple Sclerosis. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 30
Study Start Date: February 2008
Estimated Study Completion Date: February 2009
Estimated Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Detailed Description:

Stroke is the second leading cause of death in Taiwan. The morbidity and mortality of stroke is also very high worldwide. In the United States, about one third of 800,000 stoke patients became disabled; while in Taiwan, 13,000 out of 68,000 stroke patients died each year.

Diffusion tensor imaging (DTI) characterizes the three-dimensional distribution of water diffusion, which is highly anisotropic. Previous studies utilized DTI derived mean diffusivity (MD) and fractional anisotropy (FA) have found correlation between pathological changes of white matter and prognosis of stroke. However, the result was not specific due to the reason that any change at either axon or myelin sheath resulted in FA reduction. DTI, on the other hand, differentiate morphological change at axon and myelin sheath with axial and radial diffusivity, respectively. With this data, we hypothesized that the prognosis might relate to pathological change with axon post-stroke. Therefore, we conduct the study to use DTI derived axial diffusivity to evaluate the severity and to predict the functional outcome in acute ischemic stroke patient.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Acute Ischemic Stroke

Criteria

Inclusion Criteria:

  • Age greater than 20 years
  • Patients with acute pathological changes in CNS within 10 days admitted from outpatient, ER, or inpatient department
  • Confirmed diagnosis of acute ischemic stroke by clinical testings and CT scan performed by a neurologist
  • Signed informed consent from patient

Exclusion Criteria:

  • Any person with pacemaker, metal implant, claustrophobia, or any other contraindication for MR examination
  • Any person with epilepsy, brain hematomas, brain tumor, or any neurological disease confirmed by CT scan
  • Any other clinical condition which, in the opinion of the principal investigator, would not be suitable for this study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00696306

Locations
Taiwan
Taipei Medical University-Wan Fang Hospital Recruiting
Taipei, Taiwan, 116
Contact: Jia-Ying Sung, MD, PhD     +886-2-2930-7930 ext 6940     96317@wanfang.gov.tw    
Principal Investigator: Jia-Ying Sung, MD., Ph. D            
Sponsors and Collaborators
Taipei Municipal Wan Fang Hospital
Investigators
Principal Investigator: Jia-Ying Sung, MD, PhD Taipei Medical University-Wan Fang Hospital
  More Information

Responsible Party: Taipei Medical University-Wan Fang Hospital ( Jia-Ying Sung, MD, PhD )
Study ID Numbers: 2007WFCRC-002
Study First Received: June 9, 2008
Last Updated: June 11, 2008
ClinicalTrials.gov Identifier: NCT00696306  
Health Authority: Taiwan: Department of Health

Keywords provided by Taipei Municipal Wan Fang Hospital:
Acute Ischemic Stroke
Stroke
MRI
DTI
Diffusion Tensor Imaging
Outcome
Axonal Injury

Study placed in the following topic categories:
Cerebral Infarction
Stroke
Vascular Diseases
Central Nervous System Diseases
Brain Ischemia
Brain Infarction
Ischemia
Brain Diseases
Infarction
Cerebrovascular Disorders

Additional relevant MeSH terms:
Pathologic Processes
Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009