Longitudinal study of intracranial atherosclerosis using advanced imaging techniques

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

This study is trying to see how changes in the blood vessels in the brain relate to strokes by using advanced imaging techniques to look closely at intracranial atherosclerosis over time.

Quick facts

• Study type: Observational
• Enrollment: 140 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Chinese University of Hong Kong (Academic / other)
• Locations: 1 site (Hong Kong)
• Trial ID: NCT03295773 on ClinicalTrials.gov

What this trial studies

This observational study aims to investigate the morphological changes and remodeling of intracranial atherosclerosis (ICAD) using 3D-rotational angiography (3DRA). By employing this advanced imaging technique, which offers superior spatial resolution, the study seeks to analyze the geometric parameters and luminal narrowing associated with ischemic strokes. The research will be conducted under strict control of cardiovascular risk factors, with assessments performed by a neuro-radiologist and a stroke neurologist who are blinded to the time sequence of imaging. This approach allows for a detailed understanding of stroke mechanisms and the evolution of ICAD over time.

Who should consider this trial

Good fit: Ideal candidates for this study are patients aged 30 to 85 who have experienced an acute ischemic stroke due to artery-to-artery thrombo-embolism and have significant intracranial atherosclerotic stenosis.

Not a fit: Patients with stroke etiologies unrelated to intracranial atherosclerosis or those with significant extra-cranial carotid artery stenosis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnostic and therapeutic strategies for patients with ischemic stroke related to intracranial atherosclerosis.

How similar studies have performed: While the use of 3D-rotational angiography is a relatively novel approach in this context, similar studies have shown promise in enhancing the understanding of vascular conditions.

Eligibility criteria

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:

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.

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; 3D-rotational angiography; Morphology; Atherosclerosis