ClinicalTrials.gg
RecruitingNCT03291652Updated Feb 24, 2026

Morphology of Advanced Symptomatic Cerebral Plaques With High Embolic Potential

An observational study in Ischemic Stroke and Atheroscleroses, Cerebral, sponsored by Chinese University of Hong Kong. Recruiting at 1 site in Hong Kong. Open to participants aged 30 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-02-24.

Sponsored by Chinese University of Hong Kong · Observational

From the registry’s dates

  • Started Feb 2010; still recruiting 16 years 9 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
140
Ages
30 Years to 85 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 13 studies in Ischemic Stroke by Chinese University of Hong Kong — 7 open to participants now, 7 under way, none of them phase 3. Ischemic Stroke · Chinese University of Hong Kong.

Planned enrollment
6th of 10
140 · median 224
Started
2010
the only one that year
Observational
10 of 13
5 open now
Registered
2nd of 13
by date

Among the 13 studies in Ischemic Stroke by Chinese University of Hong Kong, this one is the 6th largest by planned enrollment of the 10 observational ones that give a count, is the only one that started in 2010, is one of 10 observational ones, and was the 2nd registered.

Ischemic Stroke

2,617 studies on the registry are indexed under Ischemic Stroke; 976 are open to participants now.

Browse Ischemic Stroke studies →

Open to participants now

7 of the 13 studies in Ischemic Stroke by Chinese University of Hong Kong are open now, in 2 countries. Recruiting first, the newest first:

1 more — sign in →

By country, each count listing its studies:

All 7 open studies →

Where they have run

Who these studies take

Of the 661 Ischemic Stroke studies recruiting now, 396 (60%) set no upper age limit and 62 (9%) stop at 75 or younger; 26 take children under 18; 42 take healthy volunteers.

This study: 30 Years to 85 Years · all sexes · no healthy volunteers.

The full table on the hub →

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02

Study 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 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.

03

Conditions studied

  • Ischemic Stroke
  • Atheroscleroses, Cerebral

Keywords

  • Ischemic Stroke
  • atherosclerosis
  • Plaque morphology
  • DSA/3DRA
04

Who can participate

Ages eligible
30 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients who admitted to Prince of Wales Hospital for acute stroke will be screened for eligibility.

Eligibility criteria

Inclusion Criteria:

  • Inclusion Criteria for the Symptomatic Group:

    1. Patient is 30 to 85 years of age, inclusive.
    2. 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.
    3. Patient who has no for the proposed imaging tests.
    4. Patient understands the purpose and requirements of the study, and has provided an .
  • Inclusion Criteria for the Asymptomatic Group:

    1. Patient is 30 to 85 years of age, inclusive.
    2. 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.
    3. Patient has no MES detected on TCD examination.
    4. Patient who has no contra-indication for the proposed imaging tests.
    5. Patient understands the purpose and requirements of the study, and has provided an informed consent.

Exclusion Criteria:

Subject who meets one or more of the following criteria cannot be recruited in the study:

  1. Stroke etiology uncertain or unrelated to intracranial atherosclerosis, such as cardioembolism, Moyamoya disease, small vessel disease, etc.
  2. A tandem stenosis >50% at proximal internal carotid artery.
  3. Bleeding propensity: active peptic ulcer disease, major systemic hemorrhage within 30 days, thrombocytopenia ( \<100 x 109/L), coagulopathy ( >1.5).
  4. A medical condition that would not allow the patient to adhere to the protocol or complete the study.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
140 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

    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

    Diagnostic Test: DSA/3DRA

Interventions

  • Diagnostic testDSA/3DRA

    DSA/3DRA

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Dec, 2020

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2010 (actual). Primary completion is estimated for Dec 2026, 202 months after the start.

Of 396 non-industry observational studies under Ischemic Stroke, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 140. This study's planned 202 months is above that.

Counting every sponsor, half of 438 studies reached it within 53 months; a quarter within 24 and three quarters within 127.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 20, 2017
First posted
Sep 25, 2017
StartActual
Feb 2010
Primary completionEst.
Dec 23, 2026
CompletionEst.
Dec 31, 2027
Last update
Feb 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03291652
Responsible party
Leung Wai Hong Thomas (Professor, Chinese University of Hong Kong) — Principal investigator
First posted
Sep 25, 2017
Start date
Feb 2010
Primary completion
Dec 23, 2026 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Feb 24, 2026

Study contacts

Thomas Wai Hong LEUNG, FRCP
Contact
drtleung@cuhk.edu.hk
852-35053593
Thomas Wai Hong LEUNG, FRCP
principal investigator · Chinese University of Hong Kong

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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