Ischemic StrokeNCT03291652
Morphology of Advanced Symptomatic Cerebral Plaques With High Embolic Potential
An observational study of Ischemic Stroke and Atheroscleroses, Cerebral, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
The study is to attain early recognition of the unstable plaques which have an imminent embolic risk in patients with intracranial atherosclerotic disease (IAD). Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Ischemic Stroke, Atheroscleroses, Cerebral
- What is being tested?
- DSA/3DRA
- Type of treatment
- Injection or infusion
- How many people
- 140 participants
- Where
- 1 siteHong Kong
- Study dates
- Feb 2010to 31 Dec 2027
- Phase
- Observational
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: Patients who admitted to Prince of Wales Hospital for acute stroke will be screened for eligibility.
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, a relevant intracranial atherosclerotic stenosis ≥60%, and MES detected by TCD.
- 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.
- Patient is 30 to 85 years of age, inclusive.
- Patient who has a high-grade (>60%) intracranial stenosis (signal void in MR angiography) but without infarct in the corresponding vascular territory in DWI or T2-weighted sequence.
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- Patient has no MES detected on TCD examination.
- 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
- Subject who meets one or more of the following criteria cannot be recruited in the study:
- Stroke etiology uncertain or unrelated to intracranial atherosclerosis, such as cardioembolism, Moyamoya disease, small vessel disease, etc.
- A tandem stenosis >50% at proximal 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, 852-35053593, drtleung@cuhk.edu.hk
Tiffany CHUNG, M.Phil, 852-35053856, tiffanyc@cuhk.edu.hk
About this study
The study is to attain early recognition of the unstable plaques which have an imminent embolic risk in patients with intracranial atherosclerotic disease (IAD).
Read the detailed description
Potential candidates will undergo a cranial MRI and MR angiography. Patients who are found signal void in a relevant intracranial internal carotid artery or middle cerebral artery will proceed to a 30-minute TCD monitoring for MES an angiograms will be analyzed by investigators blind to subjects' clinical information. All recruited patients will receive standard medical therapy throughout the investigation period.
- Conditions
- Ischemic Stroke, Atheroscleroses, Cerebral
- Being tested
- DSA/3DRA
- Keywords
- Ischemic Stroke, atherosclerosis, Plaque morphology, DSA/3DRA
- 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.
DSA/3DRADiagnostic test
DSA/3DRA
| Study group | Role | What they receive |
|---|---|---|
| Symptomatic stroke patient | DSA and 3DRA will be performed with access through a 4F sheath at the right femoral artery. Angiograms of intracranial arteries will be obtained by contrast injection at internal carotid artery and vertebral artery ostium from a 4F H1 catheter. Each injection will contain 10ml of iopaminro 300 diluted in 1:1 with normal saline. Each angiographic run will capture a complete series of images from the arterial phase to the end of the venous phase. A 3-dimensional rotational angiogram (a scan time of 4 seconds with 120 images) will be obtained for evaluation of plaque morphology.
2. The access site will be closely observed for hemostasis after the procedure. The neurological status and renal function will be monitored.
Diagnosis procedure: DSA/3DRA Receives: Diagnostic Test: DSA/3DRA | |
| Asymptomatic stroke patient | DSA and 3DRA will be performed with access through a 4F sheath at the right femoral artery. Angiograms of intracranial arteries will be obtained by contrast injection at internal carotid artery and vertebral artery ostium from a 4F H1 catheter. Each injection will contain 10ml of iopaminro 300 diluted in 1:1 with normal saline. Each angiographic run will capture a complete series of images from the arterial phase to the end of the venous phase. A 3-dimensional rotational angiogram (a scan time of 4 seconds with 120 images) will be obtained for evaluation of plaque morphology.
2. The access site will be closely observed for hemostasis after the procedure. The neurological status and renal function will be monitored.
Diagnosis procedure: DSA/3DRA Receives: Diagnostic Test: DSA/3DRA |
What is being measured
The primary outcome is the main question the study is designed to answer.
The plaque morphology of high-risk IAD may be distinct from the silent ones.
The morphological attributes (surface outline, angulations and plaque volume) and collateral grading will be compared between symptomatic and asymptomatic group.
Measured: Dec, 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study startFeb 2010
- Primary completion23 Dec 2026 (estimated)
- Study completion31 Dec 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-control
- 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
- NCT03291652
- Sponsor's protocol ID
- crec no. 2011.021
- 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