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

Ischemic Stroke Clinical Trial

— COIG  

Official title:

A MRI-based Study of Ischaemic Penumbra: the Correlation Between Outcome and Infarct Growth in Patients With Acute Ischemic Stroke

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01376609
• Other study ID #: BUCM-002H-ND
• Status: Not yet recruiting
• Phase: N/A
• First received: June 17, 2011
• Last updated: July 29, 2011
• Start date: August 2011
• Est. completion date: August 2013

Study information

• Verified date: June 2011
• Source: Beijing Hospital of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: National Natural Science FoundationChina: State Administration of Traditional Chinese Medicine of the People's Republic of China
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: August 2013
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ischemia
• Ischemic Stroke
• Stroke

Locations

Country	Name	City	State
China	Jianghai Ruan	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Hospital of Traditional Chinese Medicine	Beijing University of Chinese Medicine

Country where clinical trial is conducted

China,