StrokeNCT03936439
Evolution of Ischemic Stroke Subtypes in Hong Kong
An observational study of Stroke and Stroke, Acute, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Stroke is the 4th leading cause of mortality in Hong Kong. It also carries considerable socioeconomical consequences due to disability. Ischemic stroke can be classified by the TOAST classification, which includes large artery atherosclerosis, cardioembolism, small-artery occlusion and other causes (1). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke, Stroke, Acute, Neurologic Symptoms
- How many people
- 10,000 participants
- Where
- 1 siteHong Kong
- Study dates
- 7 Mar 2019to 31 Oct 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients in the stroke registry of the Prince of Wales Hospital in the recent 15 years.
Who may be able to join
- All consecutive Chinese stroke patients included in the Prince of Wales Hospital stroke registry at 2-year intervals, i.e. from 2004 to 2018
Who cannot join
- Uncertain diagnosis of stroke
- Non-Chinese patients
Trial locations and contacts
1 site in 1 country.
About this study
Stroke is the 4th leading cause of mortality in Hong Kong. It also carries considerable socioeconomical consequences due to disability.
Ischemic stroke can be classified by the TOAST classification, which includes large artery atherosclerosis, cardioembolism, small-artery occlusion and other causes (1). Among which, intracranial atherosclerosis (ICAS) had been major cause of acute ischemic stroke (AIS) in the Asia Pacific. It was estimated as high as 24.1% of AIS or transient ischemic attacks (TIAs) were attributed to ICAS in China (2). Management of ICAS related strokes has been challenging owing to its high rate of recurrence despite medical therapy. Recent randomized clinical trial suggested that aggressive medical therapy may result in reduction in recurrence compared with historical cohorts (3).
Read more
Our group has previously observed a 2.5-fold increase in atrial fibrillation related stroke over a 15-year period (4). The inverstigator also observed a decline in ICAS related AIS as well as its recurrent stroke risk throughout the recent years. Possible mechanisms include better management of metabolic risk factors and aggressive secondary prevention. Other possible reasons are increased atrial fibrillation (AF), small vessel disease (SVD) or other stroke mechanisms.
This study is aim to find the evolution of different stroke subtypes in relation to the characteristics of our stroke population over a 15-year period. This may influence territorial prevention strategy.
Read the detailed description
Five time points, i.e. 2004, 2006, 2008, 2010, 2012, 2014, 2016, 2018 are selected for analysis. All consecutive stroke patients included in the Prince of Wales Hospital stroke registry will be recruited.
Patients will be stratified according to their stroke subtypes with reference to the TOAST classification (1), which includes large artery disease, cardioembolism, small vessel occlusion, other determined causes, undetermined cause or incomplete investigations.
Stroke etiology is determined by stroke neurologists with reference to the history, physical signs, imaging including carotid duplex, transcranial doppler, computer tomography (CT), CT angiogram, magnetic resonance imaging (MRI), MR angiogram, electrocardiography (ECG) and echocardiography. Interobserver variability for stroke mechanism determination will be evaluated.
Pre-defined demographic data including age, gender, smoking status, vascular risk factors including hyperlipidaemia, hypertension, diabetes, prior stroke or TIA, etc. will be retrieved from the stroke registry.
The investigator will also compare the use of antiplatelet agents, anticoagulants, lipid-lowering agents, specific antihypertensives in the Shatin territory across the 15-year period using the CDARS.
- Conditions
- Stroke, Stroke, Acute, Neurologic Symptoms
- Keywords
- stroke
- Medical subject headings
- Stroke, Neurologic Manifestations
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 |
|---|---|---|
| Consecutive stroke patient | All consecutive stroke patients from five time points, i.e. 2004, 2006, 2008, 2010, 2012, 2014, 2016, 2018 are selected for analysis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of ischemic stroke subtype in Hong Kong with the advancement of primary care of cardiovascular control.
Stroke subtypes of the patients in the past 15 years will be classified by the reference of TOAST classification.
Measured: 31 Jul, 2019
Secondary outcomes (1)
The changes of stroke etiology in the population over 15-year period in Hong Kong
Stroke etiology will be determined by the imaging including carotid duplex, transcranial doppler, computer tomography (CT), CT angiogram, magnetic resonance imaging (MRI), MR angiogram, electrocardiography (ECG) and echocardiography.
Measured: 31 Dec, 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2019
- Study start7 Mar 2019
- Primary completion31 Oct 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. IP Yiu Ming Bonaventure, Chinese University of Hong Kong
- Investigators
- Yiu Ming Bonaventure IP, MBChB, MRCP, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03936439
- Sponsor's protocol ID
- crec 2018.645
- Status last verified
- Jun 2020
- First submitted
- 24 Apr 2019
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of Ischemic Stroke Subtypes in Hong Kong
- ClinicalTrials.gov ID
- NCT03936439
- Acronym / sponsor ID
- crec 2018.645
- Conditions
- Stroke, Stroke, Acute, Neurologic Symptoms
- Keywords
- stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,000 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 7 Mar 2019 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 3 May 2019 (actual)
- 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.
Stroke is the 4th leading cause of mortality in Hong Kong. It also carries considerable socioeconomical consequences due to disability.
Ischemic stroke can be classified by the TOAST classification, which includes large artery atherosclerosis, cardioembolism, small-artery occlusion and other causes (1). Among which, intracranial atherosclerosis (ICAS) had been major cause of acute ischemic stroke (AIS) in the Asia Pacific. It was estimated as high as 24.1% of AIS or transient ischemic attacks (TIAs) were attributed to ICAS in China (2). Management of ICAS related strokes has been challenging owing to its high rate of recurrence despite medical therapy. Recent randomized clinical trial suggested that aggressive medical therapy may result in reduction in recurrence compared with historical cohorts (3).
Our group has previously observed a 2.5-fold increase in atrial fibrillation related stroke over a 15-year period (4). The inverstigator also observed a decline in ICAS related AIS as well as its recurrent stroke risk throughout the recent years. Possible mechanisms include better management of metabolic risk factors and aggressive secondary prevention. Other possible reasons are increased atrial fibrillation (AF), small vessel disease (SVD) or other stroke mechanisms.
This study is aim to find the evolution of different stroke subtypes in relation to the characteristics of our stroke population over a 15-year period. This may influence territorial prevention strategy.
Detailed description
Five time points, i.e. 2004, 2006, 2008, 2010, 2012, 2014, 2016, 2018 are selected for analysis. All consecutive stroke patients included in the Prince of Wales Hospital stroke registry will be recruited.
Patients will be stratified according to their stroke subtypes with reference to the TOAST classification (1), which includes large artery disease, cardioembolism, small vessel occlusion, other determined causes, undetermined cause or incomplete investigations.
Stroke etiology is determined by stroke neurologists with reference to the history, physical signs, imaging including carotid duplex, transcranial doppler, computer tomography (CT), CT angiogram, magnetic resonance imaging (MRI), MR angiogram, electrocardiography (ECG) and echocardiography. Interobserver variability for stroke mechanism determination will be evaluated.
Pre-defined demographic data including age, gender, smoking status, vascular risk factors including hyperlipidaemia, hypertension, diabetes, prior stroke or TIA, etc. will be retrieved from the stroke registry.
The investigator will also compare the use of antiplatelet agents, anticoagulants, lipid-lowering agents, specific antihypertensives in the Shatin territory across the 15-year period using the CDARS.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Consecutive stroke patient | – | –All consecutive stroke patients from five time points, i.e. 2004, 2006, 2008, 2010, 2012, 2014, 2016, 2018 are selected for analysis. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients in the stroke registry of the Prince of Wales Hospital in the recent 15 years.
Key inclusion criteria (1 listed)
- All consecutive Chinese stroke patients included in the Prince of Wales Hospital stroke registry at 2-year intervals, i.e. from 2004 to 2018
Key exclusion criteria (2 listed)
- Uncertain diagnosis of stroke
- Non-Chinese patients
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
Prevalence of ischemic stroke subtype in Hong Kong with the advancement of primary care of cardiovascular control.
Time frame: 31 Jul, 2019
Stroke subtypes of the patients in the past 15 years will be classified by the reference of TOAST classification.
1 secondary outcome
The changes of stroke etiology in the population over 15-year period in Hong Kong
Time frame: 31 Dec, 2019
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Individual participant dataSharing planned: No
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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.
Yiu Ming Bonaventure IP, MBChB, MRCP principal investigator
Chinese University of Hong Kong
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 Stroke and Stroke, Acute, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 9 Jun 2020. 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 Hong Kong. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of ischemic stroke subtype in Hong Kong with the advancement of primary care of cardiovascular control. (time frame: 31 Jul, 2019). It is what the study was designed to measure, not a finding.
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 9 Jun 2020; AzTrials last refreshed its copy on 3 Nov 2026.