NCT01665729

Brief Summary

Negligence or contempt of the etiology and pathogenesis of minor ischaemic stroke in the early diagnosis and effective treatment leads to more than 40-50% of patient with recurrent episodes, and 10% patient died. Therefore, diagnosis and treatment of minor ischaemic stroke according to the etiology and pathogenesis is important. The 2007 Korean modified TOAST type got some progress, but there exists two major disadvantages: imperfect diagnosis and pathogenesis of perforator artery infarction etiology; lack of typing according to the pathogenesis of large atherosclerotic infarction and taking measures of treatment according to the new types. Recently, domestic professor Gaoshan proposes new approach to diagnose and treat minor ischaemic stroke according to the etiology and pathogenesis of CISS typing, but the pathogenesis of hypoperfusion infarction with severe stenosis of large artery is unclear. Is it low perfusion? Or artery-artery embolization? Or both? How to distinguish the pathogenesis of branch artery disease: by atherosclerosis? Or hyalinosis? Or both? How to check the validity of clinical types? This study take different interventions according to different types and observation of the long term clinical results of intervention( mortality, recurrence rate, disability rate and rate of cerebral hemorrhage and subarachnoid hemorrhage), in order to clarify the new types can indeed solve the current problem of minor ischaemic stroke with high mortality, recurrence rate, disability rate and rate of cerebral hemorrhage and subarachnoid hemorrhage.

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
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2011

Longer than P75 for all trials

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

Study Start

First participant enrolled

June 1, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

August 12, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 15, 2012

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

August 15, 2012

Status Verified

August 1, 2012

Enrollment Period

1.2 years

First QC Date

August 12, 2012

Last Update Submit

August 14, 2012

Conditions

Keywords

etiologypathogenesisminor ischaemic stroketypesintervention

Study Arms (3)

artery-artery embolus

There is no hypoperfusion ( contralateral compensatory is good )

Hypoperfusion

Contralateral compensatory not sufficient

Hypoperfusion and embolus amotic

Hypoperfusion and embolus amotic

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with new emergence of minor ischaemic stroke ( one of two conditions: (1) conscious patients with any of NIHSS score = 1,or (2) NIHSS ≤ 3 )

You may qualify if:

  • one of two conditions:
  • conscious patients with any of NIHSS score = 1,or
  • NIHSS ≤ 3

You may not qualify if:

  • patients Over 80 years of age
  • patients With serious heart, lung, liver, kidney dysfunction or
  • severe systemic complications,
  • a known tumor,
  • pregnancy,
  • having a history of cerebral hemorrhage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology,The Third Affiliated Hospital of Sun yat-sen University

Guangzhou, Guangdong, 510630, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Zhengqi Lu, prof.

    Department of Neurology,The Third Affiliated Hospital of Sun yat-sen University

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

August 12, 2012

First Posted

August 15, 2012

Study Start

June 1, 2011

Primary Completion

August 1, 2012

Study Completion

December 1, 2015

Last Updated

August 15, 2012

Record last verified: 2012-08

Locations