Evaluation of Small Vessel Disease by 3D-rotational Angiography

Stroke Clinical Trial

Official title:

Evaluation of Small Vessel Disease by 3D-rotational Angiography

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04611906
• Other study ID #: Crec 2020.386
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Cerebral Small Vessel Diseases
• Cerebrovascular Disorders
• Ischemic Stroke
• Small Vessel Cerebrovascular Disease
• Stroke
• Stroke, Acute

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