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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Beijing Hospital of Traditional Chinese Medicine.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Beijing University of Chinese Medicine
Information provided by:
Beijing Hospital of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT01376609
First received: June 17, 2011
Last updated: July 29, 2011
Last verified: June 2011
  Purpose

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
Ischemic Stroke

Study Type: Observational
Study Design: 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

Further study details as provided by Beijing Hospital of Traditional Chinese Medicine:

Estimated Enrollment: 80
Study Start Date: August 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: June 17, 2011
Last Updated: July 29, 2011
Health Authority: China: National Natural Science Foundation
China: State Administration of Traditional Chinese Medicine of the People's Republic of China

Keywords provided by Beijing Hospital of Traditional Chinese Medicine:
Cerebrovascular Disorders
Stroke
Ischaemic Stroke
Cerebral Infarction
Brain Diseases
Nervous System Diseases
Vascular Diseases
Brain Infarction
Brain Ischemia
mismatch
PWI/DWI mismatch
ischaemic penumbra
image analysis

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

ClinicalTrials.gov processed this record on September 16, 2014