Ischemic StrokeCOIGNCT01376609
The Correlation Between Outcome and Infarct Growth in Patients With Acute Ischemic Stroke
An observational study of Ischemic Stroke, run by Beijing Hospital of Traditional Chinese Medicine at 1 site in China.
Trial summary
Previous research has shown there wasn't inevitable relationship between mismatch area and infarct growth according to Volumetric-subtraction mismatch volume.The recently published on Stroke paper has proposed Coregistration mismatch to calculate the mismatch to replace ischaemic penumbra, and it reignites hope for… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ischemic Stroke
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Aug 2011to Aug 2013
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute ischaemic stroke admitted to ASU.
Who may be able to join
- Aged eighteen or above
- Acute middle cerebral artery ischemic stroke
- Stroke onset within 48 hours
- Included a complete set of initial MR images and final outcome MR images up to 1 months
Who cannot join
- History of stroke in the past 6 weeks
- Pre-existing neurological or psychiatric disease that could confound the study results such as a pre-stroke mRS score greater than 3
- CT evidence of the following conditions before enrollment:
- Significant mass effect with midline shift Evidence of intracranial hemorrhage
- With contraindication to MR such as severe allergy to contrast media
Trial locations and contacts
1 site in 1 country.
China1 site
Jianghai Ruan
Beijing, Beijing Municipality, 100078
Ruan jiang hai, MD, 86-010-64289776, ruanjianghai@126.com
About this study
Official title: A MRI-based Study of Ischaemic Penumbra: the Correlation Between Outcome and Infarct Growth in Patients With Acute Ischemic Stroke
Previous research has shown there wasn't inevitable relationship between mismatch area and infarct growth according to Volumetric-subtraction mismatch volume.The recently published on Stroke paper has proposed Coregistration mismatch to calculate the mismatch to replace ischaemic penumbra, and it reignites hope for clinical application of the PWI/DWI mismatch. But the correlation between the mismatch, calculated by Coregistration mismatch method,and the clinical outcome of the patients with acute ischemic stroke is still unknown. so the investigators plan to conduct a prospective observational cohort study.
Read the detailed description
NIHSS,mRS and MR PWI/DWI/MRA are performed within 48 hours of stroke onset and final MR T2/flair image at ≈1 month. And then,Volumetric-subtraction mismatch and Coregistered mismatch will be calculated,respectively.finally,we will assess and compare the Volumetric-subtraction mismatch and Coregistered mismatch, and to clarify which method match the clinical outcome more better.
- Conditions
- Ischemic Stroke
- Keywords
- Stroke, Ischaemic Stroke, Cerebral Infarction, Cerebrovascular Disorders, Brain Diseases, Nervous System Diseases, Vascular Diseases, Brain Infarction, Brain Ischemia, mismatch, PWI/DWI mismatch, ischaemic penumbra, image analysis
- Medical subject headings
- Ischemic Stroke, Stroke, Cerebral Infarction, Cerebrovascular Disorders, Brain Diseases, Nervous System Diseases, Vascular Diseases, Brain Infarction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2011 (estimated)
- Study startAug 2011
- Primary completionMar 2012 (estimated)
- Study completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Hospital of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01376609
- Sponsor's protocol ID
- BUCM-002H-ND
- Acronym
- COIG
- Status last verified
- Jun 2011
- First submitted
- 17 Jun 2011
- Last updated
- 1 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A MRI-based Study of Ischaemic Penumbra: the Correlation Between Outcome and Infarct Growth in Patients With Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT01376609
- Acronym / sponsor ID
- COIG / BUCM-002H-ND
- Conditions
- Ischemic Stroke
- Keywords
- Stroke, Ischaemic Stroke, Cerebral Infarction, Cerebrovascular Disorders, Brain Diseases, Nervous System Diseases, Vascular Diseases, Brain Infarction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Beijing Hospital of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Beijing University of Chinese Medicine
- Study start
- Aug 2011
- Primary completion
- Mar 2012 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 20 Jun 2011 (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.
Previous research has shown there wasn't inevitable relationship between mismatch area and infarct growth according to Volumetric-subtraction mismatch volume.The recently published on Stroke paper has proposed Coregistration mismatch to calculate the mismatch to replace ischaemic penumbra, and it reignites hope for clinical application of the PWI/DWI mismatch. But the correlation between the mismatch, calculated by Coregistration mismatch method,and the clinical outcome of the patients with acute ischemic stroke is still unknown. so the investigators plan to conduct a prospective observational cohort study.
Detailed description
NIHSS,mRS and MR PWI/DWI/MRA are performed within 48 hours of stroke onset and final MR T2/flair image at ≈1 month. And then,Volumetric-subtraction mismatch and Coregistered mismatch will be calculated,respectively.finally,we will assess and compare the Volumetric-subtraction mismatch and Coregistered mismatch, and to clarify which method match the clinical outcome more better.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute ischaemic stroke admitted to ASU.
Key inclusion criteria (4 listed)
- Aged eighteen or above
- Acute middle cerebral artery ischemic stroke
- Stroke onset within 48 hours
- Included a complete set of initial MR images and final outcome MR images up to 1 months
Key exclusion criteria (5 listed)
- History of stroke in the past 6 weeks
- Pre-existing neurological or psychiatric disease that could confound the study results such as a pre-stroke mRS score greater than 3
- CT evidence of the following conditions before enrollment:
- Significant mass effect with midline shift Evidence of intracranial hemorrhage
- With contraindication to MR such as severe allergy to contrast media
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2011.
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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.
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 Ischemic Stroke, run by Beijing Hospital of Traditional Chinese Medicine at 1 site in China.
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 5 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: status not confirmed, as of the sponsor's last update on 1 Aug 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
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 1 Aug 2011.