Ischemic StrokeNCT03295773
Morphologic Evolution and Remodeling of Intracranial Atherosclerosis: A Longitudinal Study by 3D-rotational Angiography
An observational study of Ischemic Stroke and Atheroscleroses, Cerebral, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
This study is to elucidate the morphologic evolution and remodeling of ICAD under stringent control of cardiovascular risk factors. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemic Stroke, Atheroscleroses, Cerebral
- What is being tested?
- 3DRA
- How many people
- 140 participants
- Where
- 1 siteHong Kong
- Study dates
- 22 Aug 2016to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have acute cerebral ischemic symptoms attributed to a high-grade (≥60%) stenosis at a middle cerebral artery or intracranial segment of an internal carotid artery (ICA) would be reviewed by neurologists. If their stroke etiology and relevance to ICAD based on clinical syndrome, vascular imaging features and concurrent cardiovascular risks are eligible, they would be invited to join the study.
Who may be able to join
- Patient is 30 to 85 years of age, inclusive.
- Patients who have an acute infarct in diffusion-weighted MRI compatible with artery-to-artery thrombo-embolism and a relevant intracranial atherosclerotic stenosis ≥60%.
- Patient who has no contra-indication for the proposed imaging tests.
- Patient understands the purpose and requirements of the study, and has provided an informed consent.
Who cannot join
- Patient with any of the following conditions would be excluded:
- Stroke etiology uncertain or unrelated to intracranial atherosclerosis, such as cardioembolism, Moyamoya disease, small vessel disease or primary angiitis of CNS.
- A tandem stenosis >50% at extra-cranial internal carotid artery.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Chinese University of Hong Kong
Hong Kong
Thomas Wai Hong LEUNG, FRCP, 852-35053846, drtleung@cuhk.edu.hk
Tiffany CHUNG, 852-35053856, tiffanyc@cuhk.edu.hk
About this study
This study is to elucidate the morphologic evolution and remodeling of ICAD under stringent control of cardiovascular risk factors.
Read the detailed description
The investigator has conducted extensive research on ICAD by transcranial Doppler ultrasound, CT angiography and perfusion studies, magnetic resonance imaging (MRI) and digital subtraction angiography (DSA) respectively. Currently, the investigator applied 3-dimensional rotational angiogram (3DRA), a selective intra-arterial catheter-based imaging technique that had a superior spatial resolution compared with CT, MRI or DSA in depicting minute (<3mm) angio-architecture. Through 3DRA, the investigator could appreciate the ICAD patho-anatomy from a near-infinite number of planes, analyzing the stroke mechanisms and morphological changes with much improved precision. A neuro-radiologist and a stroke neurologist blind to time sequence will measure the geometric parameters and the luminal narrowing by WASID method.
- Conditions
- Ischemic Stroke, Atheroscleroses, Cerebral
- Being tested
- 3DRA
- Keywords
- Ischemic Stroke, 3D-rotational angiography, Morphology, Atherosclerosis
- Medical subject headings
- Ischemic Stroke, Intracranial Arteriosclerosis, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3DRADiagnostic test
| Study group | Role | What they receive |
|---|---|---|
| Symptomatic stroke patient | Patients who are found signal void in a relevant intracranial internal carotid artery or middle cerebral artery (stenosis >60%) will proceed to a 3-Dimensional rotational angiography (3DRA) at baseline and in 12 months. All recruited patients will receive dual antiplatelet agents for 4 weeks, followed by aspirin alone. The investigator or neurologists shall regularly review the patients and treat the conventional cardiovascular risk factors based on four pre-specified goals, for example, LDL <1.8, HbA1c <6.0, blood pressure <140/90 and no smoking. The morphologic changes of the cerebral plaques with the intensity of the risk factor control in pre and post will be correlated. Receives: Diagnostic Test: 3DRA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphologic Evolution and Remodeling of Intracranial Atherosclerosis
The 3DRA images (the disparity in morphological attributes, including surface outline, angulations, plaque volume and distribution) of the patients in pre and post 12 month follow-up would be compared.
Measured: Dec, 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2017
- Study start22 Aug 2016
- Primary completion28 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leung Wai Hong Thomas, Chinese University of Hong Kong
- Investigators
- Thomas Wai Hong LEUNG, FRCP, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03295773
- Sponsor's protocol ID
- crec no. 2015.623
- Status last verified
- Feb 2026
- First submitted
- 20 Sep 2017
- 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
- Morphologic Evolution and Remodeling of Intracranial Atherosclerosis: A Longitudinal Study by 3D-rotational Angiography
- ClinicalTrials.gov ID
- NCT03295773
- Acronym / sponsor ID
- crec no. 2015.623
- Conditions
- Ischemic Stroke, Atheroscleroses, Cerebral
- Keywords
- Ischemic Stroke, 3D-rotational angiography, Morphology, Atherosclerosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 22 Aug 2016 (actual)
- Primary completion
- 28 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 28 Sep 2017 (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 to elucidate the morphologic evolution and remodeling of ICAD under stringent control of cardiovascular risk factors.
Detailed description
The investigator has conducted extensive research on ICAD by transcranial Doppler ultrasound, CT angiography and perfusion studies, magnetic resonance imaging (MRI) and digital subtraction angiography (DSA) respectively. Currently, the investigator applied 3-dimensional rotational angiogram (3DRA), a selective intra-arterial catheter-based imaging technique that had a superior spatial resolution compared with CT, MRI or DSA in depicting minute (<3mm) angio-architecture. Through 3DRA, the investigator could appreciate the ICAD patho-anatomy from a near-infinite number of planes, analyzing the stroke mechanisms and morphological changes with much improved precision. A neuro-radiologist and a stroke neurologist blind to time sequence will measure the geometric parameters and the luminal narrowing by WASID method.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Symptomatic stroke patient | – | Diagnostic Test: 3DRAPatients who are found signal void in a relevant intracranial internal carotid artery or middle cerebral artery (stenosis >60%) will proceed to a 3-Dimensional rotational angiography (3DRA) at baseline and in 12 months. All recruited patients will receive dual antiplatelet agents for 4 weeks, followed by aspirin alone. The investigator or neurologists shall regularly review the patients and treat the conventional cardiovascular risk factors based on four pre-specified goals, for example, LDL <1.8, HbA1c <6.0, blood pressure <140/90 and no smoking. The morphologic changes of the cerebral plaques with the intensity of the risk factor control in pre and post will be correlated. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have acute cerebral ischemic symptoms attributed to a high-grade (≥60%) stenosis at a middle cerebral artery or intracranial segment of an internal carotid artery (ICA) would be reviewed by neurologists. If their stroke etiology and relevance to ICAD based on clinical syndrome, vascular imaging features and concurrent cardiovascular risks are eligible, they would be invited to join the study.
Key inclusion criteria (4 listed)
- Patient is 30 to 85 years of age, inclusive.
- Patients who have an acute infarct in diffusion-weighted MRI compatible with artery-to-artery thrombo-embolism and a relevant intracranial atherosclerotic stenosis ≥60%.
- Patient who has no contra-indication for the proposed imaging tests.
- Patient understands the purpose and requirements of the study, and has provided an informed consent.
Key exclusion criteria (5 listed)
- Stroke etiology uncertain or unrelated to intracranial atherosclerosis, such as cardioembolism, Moyamoya disease, small vessel disease or primary angiitis of CNS.
- A tandem stenosis >50% at extra-cranial internal carotid artery.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3DRA | Diagnostic test | Symptomatic stroke patient |
Primary outcome
Morphologic Evolution and Remodeling of Intracranial Atherosclerosis
Time frame: Dec, 2019
The 3DRA images (the disparity in morphological attributes, including surface outline, angulations, plaque volume and distribution) of the patients in pre and post 12 month follow-up would be compared.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Ischemic Stroke
Recruiting
Delay AvoIding Primary Evaluation for ThRombectomy of Acute StrokE Patients With Large Vessel OCclusion in the Angiography SuiTe
Stroke, Acute
Not yet recruiting
EEG Feedback-Based Vagus Nerve Stimulation for Post-Stroke Dysphagia
Ischemic Stroke, Post-stroke Dysphagia
RecruitingObservational study
Development and Validation of Risk Prediction Models for Stroke and Cognitive Impairment in Moyamoya Disease and Moyamoya Syndrome
Moyamoya Disease, Moyamoya Syndrome
Recruiting
Impact of Atrial Fibrosis Surface Area on the Occurrence of Atrial Fibrillation in Patients With Ischemic Stroke of Undetermined Origin: a Prospective Cardiac MRI Pilot Study.
Stroke, Implantation of an Implantable Cardiac Monitor
Recruiting
Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Tablet-01)
Brainstem Stroke, ALS
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.
Thomas Wai Hong LEUNG, FRCP 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 Ischemic Stroke and Atheroscleroses, Cerebral, 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 4 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: looking for participants now, 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas Wai Hong LEUNG, FRCP (852-35053593, drtleung@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphologic Evolution and Remodeling of Intracranial Atherosclerosis (time frame: Dec, 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 24 Feb 2026.