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

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

Study Overview

• Status: Recruiting
• Conditions: Ischemic Stroke; Atheroscleroses, Cerebral
• Intervention / Treatment: Diagnostic test: 3DRA

Detailed Description

The investigator has conducted extensive research on ICAD by transcranial Doppler ultrasound, CT angiography and perfusion studies, magnetic resonance imaging (MRI) and digital subtraction angiography (DSA) respectively. Currently, the investigator applied 3-dimensional rotational angiogram (3DRA), a selective intra-arterial catheter-based imaging technique that had a superior spatial resolution compared with CT, MRI or DSA in depicting minute (<3mm) angio-architecture. Through 3DRA, the investigator could appreciate the ICAD patho-anatomy from a near-infinite number of planes, analyzing the stroke mechanisms and morphological changes with much improved precision. A neuro-radiologist and a stroke neurologist blind to time sequence will measure the geometric parameters and the luminal narrowing by WASID method.

• Study Type: Observational
• Enrollment (Anticipated): 140

Contacts and Locations

• Study Contact: Name: Thomas Wai Hong LEUNG, FRCP; Phone Number: 852-35053593; Email: drtleung@cuhk.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Chinese University of Hong Kong
    • Contact: Tiffany CHUNG; Phone Number: 852-35053856; Email: tiffanyc@cuhk.edu.hk
    • Contact: Thomas Wai Hong LEUNG, FRCP; Phone Number: 852-35053846; Email: drtleung@cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

Patient with any of the following conditions would be excluded:

1. Stroke etiology uncertain or unrelated to intracranial atherosclerosis, such as cardioembolism, Moyamoya disease, small vessel disease or primary angiitis of CNS.
2. A tandem stenosis >50% at extra-cranial internal carotid artery.
3. Bleeding propensity: active peptic ulcer disease, major systemic hemorrhage within 30 days, thrombocytopenia (platelets <100 x 109/L), coagulopathy (INR >1.5).
4. A medical condition that would not allow the patient to adhere to the protocol or complete the study.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Thomas Wai Hong LEUNG, FRCP, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2016
• Primary Completion (Anticipated): December 28, 2023
• Study Completion (Anticipated): June 30, 2024

Study Registration Dates

• First Submitted: September 20, 2017
• First Submitted That Met QC Criteria: September 25, 2017
• First Posted (Actual): September 28, 2017

Study Record Updates

• Last Update Posted (Estimate): May 8, 2023
• Last Update Submitted That Met QC Criteria: May 5, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Atherosclerosis; Ischemic Stroke; Morphology; 3D-rotational angiography
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Stroke; Intracranial Arterial Diseases; Ischemic Stroke; Atherosclerosis; Intracranial Arteriosclerosis
• Other Study ID Numbers: crec no. 2015.623

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