MRI-SWI as a Predictor of Functional Outcome in Acute Ischemic Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00696306
Recruitment Status : Completed
First Posted : June 12, 2008
Last Update Posted : April 12, 2011
Information provided by:
Taipei Medical University WanFang Hospital

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

Condition or disease
Acute Ischemic Stroke Stroke Cerebral Stroke Cerebrovascular Accident

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 be more relevant to pathological change with axon post-stroke when compare to Diffusion-Weighted imaging (DWI)/Apparent Diffusion Coefficient (ADC).

Susceptibility-weighted imaging (SWI) is a newer technique which use fully velocity compensation gradient echo sequence to receive magnitude and phase imaging. SWI can be used to detect early phase bleed, intra-arterial thrombus, cerebral venous thrombosis, thus evaluate the prognosis of patients by detect leptomeningeal collateral circulation and intravascular deoxygenation changes. We hypothesized that the prognosis is better in post-stroke patients with preserved leptomeningeal collateral circulation and venous circulation of large blood vessel. Therefore, we conduct the study to use DTI derived axial diffusivity and SWI to evaluate the severity and to predict the functional outcome in acute ischemic stroke patient.

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Diffusion Tensor Imaging (DTI) and Susceptibility Weighted Imaging (SWI) as a Predictor of Functional Outcome in Acute Ischemic Stroke
Study Start Date : February 2008
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Primary Outcome Measures :
  1. To correlate the prognosis of acute ischemic stroke with the result of MRI-DTI and the result of SWI. [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. To establish the DTI/SWI 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Acute Ischemic Stroke

Inclusion Criteria:

  • Age greater than 20 years
  • Patients with acute pathological changes in CNS within 7 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00696306

Taipei Medical University-Wan Fang Hospital
Taipei, Taiwan, 116
Sponsors and Collaborators
Taipei Medical University WanFang Hospital
Principal Investigator: Chin-I Chen, MD Taipei Medical University-Wan Fang Hospital

Responsible Party: Chin-I Chen, MD, PhD, Taipei Medical University-Wan Fang Hospital Identifier: NCT00696306     History of Changes
Other Study ID Numbers: 2007WFCRC-002
First Posted: June 12, 2008    Key Record Dates
Last Update Posted: April 12, 2011
Last Verified: April 2011

Keywords provided by Taipei Medical University WanFang Hospital:
Acute Ischemic Stroke
Diffusion Tensor Imaging
Susceptibility Weighted Imaging
Axonal Injury

Additional relevant MeSH terms:
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia