Evaluation of Small Vessel Disease by 3D-rotational Angiography

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04611906

Enrollment

Registered

2020-11-02

Start date

2020-11-05

Completion date

2025-06-30

Last updated

2026-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Stroke, Small Vessel Cerebrovascular Disease, Stroke, Stroke, Acute

Keywords

stroke, small vessel disease, 3D-rotational Angiography, Ischemic stroke

Brief summary

This study is aimed to elucidate the factors affecting the remodeling process of arteriolosclerosis under current practice recommendations. Such knowledge may improve the understanding of cerebral small vessel disease (cSVD) mechanism, define pharmacological therapy and suggest treatment target.

Detailed description

Around 68 patients who have acute cerebral ischemic symptoms attributed by cSVD will be recruited. Stroke etiology will be determined by Neurologists based on clinical syndrome, vascular imaging features and concurrent cardiovascular risks. The time window for recruitment is 4 weeks from the qualifying stroke. After an informed consent for the study, potential candidates will undergo a cranial MRI and MR angiography. Patients who are found to have acute or subacute lacunar infarcts (defined as an infarct diameter \< 15mm) in the territories supplied by the lateral lenticulostriate arteries, i.e. internal capsule, putamen, external capsular or corona radiata, will proceed to a 3-Dimensional rotational angiography (3DRA) at baseline and in 12 months. All recruited patients will receive single antiplatelet agents and statin. Their cognition, mobility and treat cardiovascular risk factors based on 4 pre-specified goals (as elaborated in Study Procedures) will also be regularly reviewed.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

30 Years to 85 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Morphological change	one year after recruitment	The pre and post imaging in ischemic stroke patients by 3D-rotational angiography

Countries

Hong Kong

Contacts

PRINCIPAL_INVESTIGATORYiu Ming Bonaventure IP, MBChB, MRCP

Chinese University of Hong Kong

Outcome results