Clinical trial NCT04611906: Evaluation of Small Vessel Disease by 3D-rotational Angiography
Official title: Evaluation of Small Vessel Disease by 3D-rotational Angiography
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke, Acute
Stroke
Small Vessel Cerebrovascular Disease
Ischemic Stroke
Keywords: stroke
small vessel disease
3D-rotational Angiography
Ischemic stroke
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2020-11-02
Enrollment: 68
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All ischemic stroke patients who have admitted to the Prince of Wales Hospital will be screened.

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.

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.

Primary outcomes:
measure: Morphological change
timeFrame: one year after recruitment
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Yiu Ming Bonaventure IP, MBChB, MRCP
role: PRINCIPAL_INVESTIGATOR
References: