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RecruitingNCT03295773Updated Feb 24, 2026

Morphologic Evolution and Remodeling of Intracranial Atherosclerosis: A Longitudinal Study by 3D-rotational Angiography

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 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-02-24.

Sponsored by Chinese University of Hong Kong · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
140
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Ischemic Stroke
  • Atheroscleroses, Cerebral

Keywords

  • Ischemic Stroke
  • 3D-rotational angiography
  • Morphology
  • Atherosclerosis
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Inclusion criteria

  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 and a relevant intracranial atherosclerotic stenosis ≥60%.
  3. Patient who has no contra-indication for the proposed imaging tests.
  4. Patient understands the purpose and requirements of the study, and has provided an informed consent.

Exclusion criteria

Exclusion Criteria:

Patient with any of the following conditions would be excluded:

  1. Stroke etiology uncertain or unrelated to intracranial atherosclerosis, such as cardioembolism, Moyamoya disease, small vessel disease or primary angiitis of CNS.
  2. A tandem stenosis >50% at extra-cranial internal carotid artery.
  3. Bleeding propensity: active peptic ulcer disease, major systemic hemorrhage within 30 days, thrombocytopenia (platelets \<100 x 109/L), coagulopathy (INR >1.5).
  4. A medical condition that would not allow the patient to adhere to the protocol or complete the study.
04

Study design

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

Groups and cohorts

  • 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.

    Diagnostic Test: 3DRA

Interventions

  • Diagnostic test3DRA
05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Dec, 2019

06

Study locations

1 of 1 sites recruiting
  • Chinese University of Hong Kong
    Hong Kong, Hong Kong
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03295773
Lead sponsor
Chinese University of Hong Kong
Responsible party
Leung Wai Hong Thomas (Professor, Chinese University of Hong Kong) — Principal investigator
First posted
Sep 28, 2017
Start date
Aug 22, 2016
Primary completion
Dec 28, 2026 (estimated)
Completion
Jun 30, 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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