Evaluating small vessel disease using advanced imaging techniques

Evaluation of Small Vessel Disease by 3D-rotational Angiography

This study is trying to see how advanced imaging can help understand changes in small blood vessels in the brain of stroke patients and how these changes affect their thinking and movement over time.

Quick facts

• Study type: Observational
• Enrollment: 68 (estimated)
• Ages: 30 Years to 85 Years
• Sex: All
• Sponsor: Chinese University of Hong Kong (Academic / other)
• Locations: 1 site (Hong Kong)
• Trial ID: NCT04611906 on ClinicalTrials.gov

What this trial studies

This observational study aims to understand the factors influencing the remodeling process of arteriolosclerosis in patients with acute cerebral ischemic symptoms attributed to small vessel disease. Approximately 68 Chinese patients aged 30 to 85 will be recruited within four weeks of experiencing a stroke. Participants will undergo cranial MRI and MR angiography, followed by 3D-rotational angiography at baseline and again after 12 months. The study will also monitor cognitive function, mobility, and cardiovascular risk factors while all patients receive standard pharmacological treatment.

Who should consider this trial

Good fit: Ideal candidates are Chinese patients aged 30 to 85 with acute lacunar infarcts due to small vessel disease.

Not a fit: Patients with stroke etiologies unrelated to small vessel disease or those with significant bleeding risks may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the understanding of cerebral small vessel disease and improve treatment strategies for patients with ischemic strokes.

How similar studies have performed: While similar studies have explored small vessel disease, this specific approach using 3D-rotational angiography is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Patient is Chinese ONLY
2. Patient is 30 to 85 years of age, inclusive.
3. Patients who have an acute lacunar infarct in diffusion-weighted MRI compatible with small vessel disease in territories supplied by the lateral lenticulostriate arteries without relevant intracranial atherosclerotic stenosis ≥60%.
4. Patient who has no contra-indication for the proposed imaging tests.
5. Patient who understands the purpose and requirements of the study, and has an informed consent.
6. Patient who has Modified Functional Ambulation Classification 4 or above.

Exclusion Criteria:

1. Stroke etiology uncertain or unrelated to small vessel disease, such as cardioembolism, Moyamoya disease, ICAD or primary angiitis of CNS.
2. Bleeding propensity: active peptic ulcer disease, major systemic hemorrhage within 30 days, thrombocytopenia (platelets \<100 x 109/L), coagulopathy (INR \>1.5).
3. A medical condition that would not allow the patient to adhere to the protocol or complete the study.
4. Patients with severe renal impairment.
5. Patients who are taking warfarin and non-vitamin K antagonist oral anticoagulants would also be excluded.

Where this trial is running

Hong Kong

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

Study contacts

• Principal investigator: Yiu Ming Bonaventure IP, MBChB, MRCP — Chinese University of Hong Kong
• Study coordinator: Yiu Ming Bonaventure IP, MRCP

Conditions Stroke, Acute; Stroke; Small Vessel Cerebrovascular Disease; Ischemic Stroke; stroke; small vessel disease; 3D-rotational Angiography; Ischemic stroke