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

This study has been completed.
Sponsor:
Information provided by:
Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier:
NCT00696306
First received: June 9, 2008
Last updated: April 11, 2011
Last verified: April 2011
  Purpose

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
Acute Ischemic Stroke
Stroke
Cerebral Stroke
Cerebrovascular Accident

Study Type: Observational
Study Design: 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

Further study details as provided by Taipei Medical University WanFang Hospital:

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

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: February 2008
Study Completion Date: February 2011
Primary Completion Date: February 2011 (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 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.

  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 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00696306

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

No publications provided

Responsible Party: Chin-I Chen, MD, PhD, Taipei Medical University-Wan Fang Hospital
ClinicalTrials.gov Identifier: NCT00696306     History of Changes
Other Study ID Numbers: 2007WFCRC-002
Study First Received: June 9, 2008
Last Updated: April 11, 2011
Health Authority: Taiwan: Department of Health

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

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

ClinicalTrials.gov processed this record on September 22, 2014