NCT01376609

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 20, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

August 1, 2011

Status Verified

June 1, 2011

Enrollment Period

7 months

First QC Date

June 17, 2011

Last Update Submit

July 29, 2011

Conditions

Keywords

StrokeIschaemic StrokeCerebral InfarctionCerebrovascular DisordersBrain DiseasesNervous System DiseasesVascular DiseasesBrain InfarctionBrain IschemiamismatchPWI/DWI mismatchischaemic penumbraimage analysis

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with acute ischaemic stroke admitted to ASU.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jianghai Ruan

Beijing, Beijing Municipality, 100078, China

Location

MeSH Terms

Conditions

Ischemic StrokeStrokeCerebral InfarctionCerebrovascular DisordersBrain DiseasesNervous System DiseasesVascular DiseasesBrain InfarctionBrain Ischemia

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesCardiovascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 17, 2011

First Posted

June 20, 2011

Study Start

August 1, 2011

Primary Completion

March 1, 2012

Study Completion

August 1, 2013

Last Updated

August 1, 2011

Record last verified: 2011-06

Locations