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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Ischemic Stroke; Stroke, Acute; Small Vessel Cerebrovascular Disease

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.

• Study Type: Observational
• Enrollment (Estimated): 68

Contacts and Locations

• Study Contact: Name: Yiu Ming Bonaventure Ip, MRCP; Phone Number: 852-35053856; Email: iym984@ha.org.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Chinese University of Hong Kong
    • Contact: Yiu Ming Bonaventure Ip, MRCP; Phone Number: 852-35053856; Email: iym984@ha.org.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All ischemic stroke patients who have admitted to the Prince of Wales Hospital will be screened.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Stroke patient; Patients who have acute cerebral ischemic symptoms attributed by cSVD can be recruited into this study. Eligible patients will be screened by Neurologists based on the inclusion and exclusion criteria. The time window for recruitment of the patient is 4 weeks from the qualifying stroke.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Yiu Ming Bonaventure IP, MBChB, MRCP, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2020
• Primary Completion (Estimated): October 31, 2029
• Study Completion (Estimated): April 30, 2030

Study Registration Dates

• First Submitted: October 27, 2020
• First Submitted That Met QC Criteria: October 27, 2020
• First Posted (Actual): November 2, 2020

Study Record Updates

• Last Update Posted (Estimated): June 19, 2023
• Last Update Submitted That Met QC Criteria: June 16, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: stroke; Ischemic stroke; small vessel disease; 3D-rotational Angiography
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Cerebrovascular Disorders; Cerebral Small Vessel Diseases
• Other Study ID Numbers: Crec 2020.386

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No