Ischaemic StrokeNCT01665729
Diagnosis and Treatment of Minor Ischaemic Stroke According to the Etiology and Pathogenesis
An observational study of Ischaemic Stroke, run by Li Haiyan at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Ischaemic Stroke
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- Jun 2011to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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 )
Who may be able to join
- one of two conditions:
- conscious patients with any of NIHSS score = 1,or
- NIHSS ≤ 3
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Neurology,The Third Affiliated Hospital of Sun yat-sen University
Guangzhou, Guangdong, 510630
Zhengqi Lu, prof., 86 13570102668, lzq1828@yahoo.com.cn
Haiyan Li, 86 15920474159, lihaiyan162@yahoo.com.cn
About this study
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.
- Conditions
- Ischaemic Stroke
- Keywords
- etiology, pathogenesis, minor ischaemic stroke, types, intervention
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| artery-artery embolus | There is no hypoperfusion ( contralateral compensatory is good ) | |
| Hypoperfusion | Contralateral compensatory not sufficient | |
| Hypoperfusion and embolus amotic | Hypoperfusion and embolus amotic |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2012 (estimated)
- Study startJun 2011
- Primary completionAug 2012
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischaemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Li Haiyan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Li Haiyan, Third Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Zhengqi Lu, prof., Study chair, Department of Neurology,The Third Affiliated Hospital of Sun yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01665729
- Sponsor's protocol ID
- 2011-2-48
- Status last verified
- Aug 2012
- First submitted
- 12 Aug 2012
- Last updated
- 15 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis and Treatment of Minor Ischaemic Stroke According to the Etiology and Pathogenesis
- ClinicalTrials.gov ID
- NCT01665729
- Acronym / sponsor ID
- 2011-2-48
- Conditions
- Ischaemic Stroke
- Keywords
- etiology, pathogenesis, minor ischaemic stroke, types, intervention
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Li HaiyanUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Dec 2015 (estimated)
- First posted
- 15 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| artery-artery embolus | – | –There is no hypoperfusion ( contralateral compensatory is good ) |
| Hypoperfusion | – | –Contralateral compensatory not sufficient |
| Hypoperfusion and embolus amotic | – | –Hypoperfusion and embolus amotic |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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 )
Key inclusion criteria (3 listed)
- conscious patients with any of NIHSS score = 1,or
- NIHSS ≤ 3
Key exclusion criteria (6 listed)
- patients Over 80 years of age
- patients With serious heart, lung, liver, kidney dysfunction or
- severe systemic complications,
- a known tumor,
- pregnancy,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhengqi Lu, prof. study chair
Department of Neurology,The Third Affiliated Hospital of Sun yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischaemic Stroke, run by Li Haiyan at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhengqi Lu, prof. (86 13570102668, lzq1828@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2012; AzTrials last refreshed its copy on 8 Nov 2026.