NCT04611906

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 2, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

November 5, 2020

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

February 24, 2026

Status Verified

February 1, 2026

Enrollment Period

4.7 years

First QC Date

October 27, 2020

Last Update Submit

February 21, 2026

Conditions

Keywords

strokesmall vessel disease3D-rotational AngiographyIschemic stroke

Outcome Measures

Primary Outcomes (1)

  • Morphological change

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

    one year after recruitment

Study Arms (1)

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.

Eligibility Criteria

Age30 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

StrokeCerebral Small Vessel DiseasesIschemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Yiu Ming Bonaventure IP, MBChB, MRCP

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist resident

Study Record Dates

First Submitted

October 27, 2020

First Posted

November 2, 2020

Study Start

November 5, 2020

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

February 24, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations