Examining the structure of dangerous brain plaques in stroke patients

Morphology of Advanced Symptomatic Cerebral Plaques With High Embolic Potential

This study is trying to find out if certain dangerous brain plaques in stroke patients can be identified using advanced imaging techniques to help prevent future strokes.

Quick facts

• Study type: Observational
• Enrollment: 140 (estimated)
• Ages: 30 Years to 85 Years
• Sex: All
• Sponsor: Chinese University of Hong Kong (Academic / other)
• Locations: 1 site (Hong Kong)
• Trial ID: NCT03291652 on ClinicalTrials.gov

What this trial studies

This observational study aims to identify unstable plaques in patients with intracranial atherosclerotic disease that pose a high risk for embolic events. Participants will undergo cranial MRI and MR angiography, followed by transcranial Doppler monitoring to detect microembolic signals. The analysis of angiograms will be conducted by investigators who are unaware of the patients' clinical backgrounds. Throughout the study, all participants will receive standard medical therapy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 30 to 85 with significant intracranial atherosclerotic stenosis and evidence of recent ischemic events.

Not a fit: Patients without significant intracranial stenosis or those who do not meet the age and clinical criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved early detection of high-risk plaques, potentially reducing the incidence of ischemic strokes.

How similar studies have performed: While similar studies have explored plaque morphology, this specific approach focusing on high embolic potential in symptomatic patients is relatively novel.

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 contra-indication for the proposed imaging tests.
  4. Patient understands the purpose and requirements of the study, and has provided an informed consent.
* 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 (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.

Where this trial is running

Hong Kong

• Chinese University of Hong Kong — Hong Kong, Hong Kong (Recruiting)

Study contacts

• Principal investigator: Thomas Wai Hong LEUNG, FRCP — Chinese University of Hong Kong
• Study coordinator: Thomas Wai Hong LEUNG, FRCP

Conditions Ischemic Stroke; Atheroscleroses, Cerebral; atherosclerosis; Plaque morphology; DSA/3DRA