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The Correlation Between Outcome and Infarct Growth in Patients With Acute Ischemic Stroke (COIG)

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ClinicalTrials.gov Identifier: NCT01376609
Recruitment Status : Unknown
Verified June 2011 by Beijing Hospital of Traditional Chinese Medicine.
Recruitment status was:  Not yet recruiting
First Posted : June 20, 2011
Last Update Posted : August 1, 2011
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief 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 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.

Condition or disease
Ischemic Stroke

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

Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A MRI-based Study of Ischaemic Penumbra: the Correlation Between Outcome and Infarct Growth in Patients With Acute Ischemic Stroke
Study Start Date : August 2011
Estimated Primary Completion Date : March 2012
Estimated Study Completion Date : August 2013
Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with acute ischaemic stroke admitted to ASU.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01376609


Locations
China, Beijing
Jianghai Ruan Not yet recruiting
Beijing, Beijing, China, 100078
Contact: Ruan jiang hai, MD    86-010-64289776    ruanjianghai@126.com   
Sponsors and Collaborators
Beijing Hospital of Traditional Chinese Medicine
Beijing University of Chinese Medicine
More Information

Responsible Party: Jianghai Ruan, Dept.of Neurology,Beijing Dongfang Hospital, Beijing University of Chinese Traditional Medicine,Beijing,China
ClinicalTrials.gov Identifier: NCT01376609     History of Changes
Other Study ID Numbers: BUCM-002H-ND
First Posted: June 20, 2011    Key Record Dates
Last Update Posted: August 1, 2011
Last Verified: June 2011

Keywords provided by Beijing Hospital of Traditional Chinese Medicine:
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

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