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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04611906
Other study ID # Crec 2020.386
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 5, 2020
Est. completion date April 30, 2030

Study information

Verified date June 2023
Source Chinese University of Hong Kong
Contact Yiu Ming Bonaventure IP, MRCP
Phone 852-35053856
Email iym984@ha.org.hk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 68
Est. completion date April 30, 2030
Est. primary completion date October 31, 2029
Accepts healthy volunteers No
Gender All
Age group 30 Years to 85 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Hong Kong Chinese University of Hong Kong Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

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