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NCT Number: NCT03291652

Morphology of Advanced Symptomatic Cerebral Plaques With High Embolic Potential

The study is to attain early recognition of the unstable plaques which have an imminent embolic risk in patients with intracranial atherosclerotic disease (IAD).

Recruiting

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Key information

Age range

30 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Inclusion Criteria for the Symptomatic Group:
  • 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.
  • Inclusion Criteria for the Asymptomatic Group:
  • 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.
  • 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.

Exclusion criteria

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.

Treatment and study plan

DSA/3DRA

Diagnostic Test

DSA/3DRA

Primary outcomes

  1. The plaque morphology of high-risk IAD may be distinct from the silent ones.

    Time frame: Dec, 2020

    The morphological attributes (surface outline, angulations and plaque volume) and collateral grading will be compared between symptomatic and asymptomatic group.

Study contacts

Contact information is provided by the study sponsor or research team.

Thomas Wai Hong LEUNG, FRCP

CONTACT

[email protected]

852-35053593

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Important dates

Study start
2010
Primary completion
2026
Study completion
2027
First posted
Sep 25, 2017
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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