Morphologic Evolution and Remodeling of Intracranial Atherosclerosis: A Longitudinal Study by 3D-rotational Angiography

NCT03295773 | Recruiting

• 1 other identifier: crec no. 2015.623
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to elucidate the morphologic evolution and remodeling of ICAD under stringent control of cardiovascular risk factors.

Conditions

Ischemic Stroke; Atheroscleroses, Cerebral

Keywords

Ischemic Stroke; 3D-rotational angiography; Morphology; Atherosclerosis

Outcome Measures

Primary Outcomes (1)

• Morphologic Evolution and Remodeling of Intracranial Atherosclerosis

  The 3DRA images (the disparity in morphological attributes, including surface outline, angulations, plaque volume and distribution) of the patients in pre and post 12 month follow-up would be compared.

  Dec, 2019

Study Arms (1)

Symptomatic stroke patient

Patients who are found signal void in a relevant intracranial internal carotid artery or middle cerebral artery (stenosis \>60%) will proceed to a 3-Dimensional rotational angiography (3DRA) at baseline and in 12 months. All recruited patients will receive dual antiplatelet agents for 4 weeks, followed by aspirin alone. The investigator or neurologists shall regularly review the patients and treat the conventional cardiovascular risk factors based on four pre-specified goals, for example, LDL \<1.8, HbA1c \<6.0, blood pressure \<140/90 and no smoking. The morphologic changes of the cerebral plaques with the intensity of the risk factor control in pre and post will be correlated.

Diagnostic Test: 3DRA

Interventions

3DRA DIAGNOSTIC_TEST

Symptomatic stroke patient

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have acute cerebral ischemic symptoms attributed to a high-grade (≥60%) stenosis at a middle cerebral artery or intracranial segment of an internal carotid artery (ICA) would be reviewed by neurologists. If their stroke etiology and relevance to ICAD based on clinical syndrome, vascular imaging features and concurrent cardiovascular risks are eligible, they would be invited to join the study.

You may qualify if:

• Patient is 30 to 85 years of age, inclusive.
• Patients who have an acute infarct in diffusion-weighted MRI compatible with artery-to-artery thrombo-embolism and a relevant intracranial atherosclerotic stenosis ≥60%.
• Patient who has no contra-indication for the proposed imaging tests.
• Patient understands the purpose and requirements of the study, and has provided an informed consent.

You may not qualify if:

• Patient with any of the following conditions would be excluded:
• Stroke etiology uncertain or unrelated to intracranial atherosclerosis, such as cardioembolism, Moyamoya disease, small vessel disease or primary angiitis of CNS.
• A tandem stenosis \>50% at extra-cranial internal carotid artery.
• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke; Intracranial Arteriosclerosis; Atherosclerosis

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Arterial Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Thomas Wai Hong LEUNG, FRCP

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Wai Hong LEUNG, FRCP

CONTACT

852-35053593; drtleung@cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 20, 2017
• First Posted: September 28, 2017
• Study Start: August 22, 2016
• Primary Completion (Estimated): December 28, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)