Stroke, AcuteNCT04611906
Evaluation of Small Vessel Disease by 3D-rotational Angiography
An observational study of Stroke, Acute and Stroke, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
This study is aimed to elucidate the factors affecting the remodeling process of arteriolosclerosis under current practice recommendations. Such knowledge may improve the understanding of cerebral small vessel disease (cSVD) mechanism, define pharmacological therapy and suggest treatment target. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Stroke, Acute, Stroke, Small Vessel Cerebrovascular Disease
- How many people
- 24 participants
- Where
- 1 siteHong Kong
- Study dates
- 5 Nov 2020to 30 Jun 2025
- 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 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All ischemic stroke patients who have admitted to the Prince of Wales Hospital will be screened.
Who may be able to join
- Patient is Chinese ONLY
- Patient is 30 to 85 years of age, inclusive.
- Patients who have an acute lacunar infarct in diffusion-weighted MRI compatible with small vessel disease in territories supplied by the lateral lenticulostriate arteries without relevant intracranial atherosclerotic stenosis ≥60%.
- Patient who has no contra-indication for the proposed imaging tests.
- Patient who understands the purpose and requirements of the study, and has an informed consent.
- Patient who has Modified Functional Ambulation Classification 4 or above.
Who cannot join
- Stroke etiology uncertain or unrelated to small vessel disease, such as cardioembolism, Moyamoya disease, ICAD or primary angiitis of CNS.
- Bleeding propensity: active peptic ulcer disease, major systemic hemorrhage within 30 days, thrombocytopenia (platelets <100 x 109/L), coagulopathy (INR >1.5).
- A medical condition that would not allow the patient to adhere to the protocol or complete the study.
- Patients with severe renal impairment.
- Patients who are taking warfarin and non-vitamin K antagonist oral anticoagulants would also be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
This study is aimed to elucidate the factors affecting the remodeling process of arteriolosclerosis under current practice recommendations. Such knowledge may improve the understanding of cerebral small vessel disease (cSVD) mechanism, define pharmacological therapy and suggest treatment target.
Read the detailed description
Around 68 patients who have acute cerebral ischemic symptoms attributed by cSVD will be recruited. Stroke etiology will be determined by Neurologists based on clinical syndrome, vascular imaging features and concurrent cardiovascular risks. The time window for recruitment is 4 weeks from the qualifying stroke.
After an informed consent for the study, potential candidates will undergo a cranial MRI and MR angiography. Patients who are found to have acute or subacute lacunar infarcts (defined as an infarct diameter < 15mm) in the territories supplied by the lateral lenticulostriate arteries, i.e. internal capsule, putamen, external capsular or corona radiata, will proceed to a 3-Dimensional rotational angiography (3DRA) at baseline and in 12 months. All recruited patients will receive single antiplatelet agents and statin. Their cognition, mobility and treat cardiovascular risk factors based on 4 pre-specified goals (as elaborated in Study Procedures) will also be regularly reviewed.
- Keywords
- stroke, small vessel disease, 3D-rotational Angiography, Ischemic stroke
- Medical subject headings
- Stroke, Cerebral Small Vessel Diseases, 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 |
|---|---|---|
| Stroke patient | Patients who have acute cerebral ischemic symptoms attributed by cSVD can be recruited into this study. Eligible patients will be screened by Neurologists based on the inclusion and exclusion criteria. The time window for recruitment of the patient is 4 weeks from the qualifying stroke. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphological change
The pre and post imaging in ischemic stroke patients by 3D-rotational angiography
Measured: one year after recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2020
- Study start5 Nov 2020
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies 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
- Prospective
- Enrolment
- 24 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
- NCT04611906
- Sponsor's protocol ID
- Crec 2020.386
- Status last verified
- Feb 2026
- First submitted
- 27 Oct 2020
- Last updated
- 24 Feb 2026
- 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 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Small Vessel Disease by 3D-rotational Angiography
- ClinicalTrials.gov ID
- NCT04611906
- Acronym / sponsor ID
- Crec 2020.386
- Keywords
- stroke, small vessel disease, 3D-rotational Angiography, Ischemic stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 5 Nov 2020 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 2 Nov 2020 (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.
This study is aimed to elucidate the factors affecting the remodeling process of arteriolosclerosis under current practice recommendations. Such knowledge may improve the understanding of cerebral small vessel disease (cSVD) mechanism, define pharmacological therapy and suggest treatment target.
Detailed description
Around 68 patients who have acute cerebral ischemic symptoms attributed by cSVD will be recruited. Stroke etiology will be determined by Neurologists based on clinical syndrome, vascular imaging features and concurrent cardiovascular risks. The time window for recruitment is 4 weeks from the qualifying stroke.
After an informed consent for the study, potential candidates will undergo a cranial MRI and MR angiography. Patients who are found to have acute or subacute lacunar infarcts (defined as an infarct diameter < 15mm) in the territories supplied by the lateral lenticulostriate arteries, i.e. internal capsule, putamen, external capsular or corona radiata, will proceed to a 3-Dimensional rotational angiography (3DRA) at baseline and in 12 months. All recruited patients will receive single antiplatelet agents and statin. Their cognition, mobility and treat cardiovascular risk factors based on 4 pre-specified goals (as elaborated in Study Procedures) will also be regularly reviewed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stroke patient | – | –Patients who have acute cerebral ischemic symptoms attributed by cSVD can be recruited into this study. Eligible patients will be screened by Neurologists based on the inclusion and exclusion criteria. The time window for recruitment of the patient is 4 weeks from the qualifying stroke. |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All ischemic stroke patients who have admitted to the Prince of Wales Hospital will be screened.
Key inclusion criteria (6 listed)
- Patient is Chinese ONLY
- Patient is 30 to 85 years of age, inclusive.
- Patients who have an acute lacunar infarct in diffusion-weighted MRI compatible with small vessel disease in territories supplied by the lateral lenticulostriate arteries without relevant intracranial atherosclerotic stenosis ≥60%.
- Patient who has no contra-indication for the proposed imaging tests.
- Patient who understands the purpose and requirements of the study, and has an informed consent.
Key exclusion criteria (5 listed)
- Stroke etiology uncertain or unrelated to small vessel disease, such as cardioembolism, Moyamoya disease, ICAD or primary angiitis of CNS.
- Bleeding propensity: active peptic ulcer disease, major systemic hemorrhage within 30 days, thrombocytopenia (platelets <100 x 109/L), coagulopathy (INR >1.5).
- A medical condition that would not allow the patient to adhere to the protocol or complete the study.
- Patients with severe renal impairment.
- Patients who are taking warfarin and non-vitamin K antagonist oral anticoagulants would also be excluded.
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
Morphological change
Time frame: one year after recruitment
The pre and post imaging in ischemic stroke patients by 3D-rotational angiography
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 24 Feb 2026.
- 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, Acute and Stroke, 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 6 inclusion and 5 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 24 Feb 2026. 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?
Morphological change (time frame: one year after recruitment). 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 24 Feb 2026.