Acute Ischemic StrokeNCT00696306
MRI-SWI as a Predictor of Functional Outcome in Acute Ischemic Stroke
An observational study of Acute Ischemic Stroke and Stroke, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Acute Ischemic Stroke, Stroke, Cerebral Stroke
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2008to Feb 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acute Ischemic Stroke
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diffusion Tensor Imaging (DTI) and Susceptibility Weighted Imaging (SWI) as a Predictor of Functional Outcome in Acute Ischemic Stroke
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.
Read the 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.
- Keywords
- Acute Ischemic Stroke, Stroke, MRI, DTI, Diffusion Tensor Imaging, SWI, Susceptibility Weighted Imaging, Outcome, Axonal Injury
- Medical subject headings
- Ischemic Stroke, Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
To correlate the prognosis of acute ischemic stroke with the result of MRI-DTI and the result of SWI.
Measured: 6 months
Secondary outcomes (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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2008 (estimated)
- Study startFeb 2008
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Chin-I Chen, MD, Principal investigator, Taipei Medical University-Wan Fang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00696306
- Sponsor's protocol ID
- 2007WFCRC-002
- Status last verified
- Apr 2011
- First submitted
- 9 Jun 2008
- Last updated
- 12 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diffusion Tensor Imaging (DTI) and Susceptibility Weighted Imaging (SWI) as a Predictor of Functional Outcome in Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT00696306
- Acronym / sponsor ID
- 2007WFCRC-002
- Keywords
- Acute Ischemic Stroke, Stroke, MRI, DTI, Diffusion Tensor Imaging, SWI, Susceptibility Weighted Imaging, Outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 12 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute Ischemic Stroke
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To correlate the prognosis of acute ischemic stroke with the result of MRI-DTI and the result of SWI.
Time frame: 6 months
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2011.
Related trials for Acute Ischemic Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Not yet recruitingPhase 2/3
A Multicenter, Open-label, Randomized, Non-inferiority Clinical Trial With Blinded Endpoint Assessment of Early Tirofiban After Intravenous Thrombolysis in Acute Ischemic Stroke
Acute Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chin-I Chen, MD principal investigator
Taipei Medical University-Wan Fang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischemic Stroke and Stroke, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To correlate the prognosis of acute ischemic stroke with the result of MRI-DTI and the result of SWI. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2011.