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OpenTrials
Completed

NCT Number: NCT04611906

Evaluation of Small Vessel Disease by 3D-rotational Angiography

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.

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Key information

Age range

30 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chinese University of Hong Kong

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient is Chinese ONLY
  • Patient is 30 to 85 years of age, inclusive.
  • 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%.
  • Patient who has no contra-indication for the proposed imaging tests.
  • Patient who understands the purpose and requirements of the study, and has an informed consent.
  • Patient who has Modified Functional Ambulation Classification 4 or above.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Morphological change

    Time frame: one year after recruitment

    The pre and post imaging in ischemic stroke patients by 3D-rotational angiography

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Nov 2, 2020
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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