Morphology of Advanced Symptomatic Cerebral Plaques With High Embolic Potential

The study is to attain early recognition of the unstable plaques which have an imminent embolic risk in patients with intracranial atherosclerotic disease (IAD).

Study Overview

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

Detailed Description

Potential candidates will undergo a cranial MRI and MR angiography. Patients who are found signal void in a relevant intracranial internal carotid artery or middle cerebral artery will proceed to a 30-minute TCD monitoring for MES an angiograms will be analyzed by investigators blind to subjects' clinical information. All recruited patients will receive standard medical therapy throughout the investigation period.

• 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: Thomas Wai Hong LEUNG, FRCP; Phone Number: 852-35053593; Email: drtleung@cuhk.edu.hk
    • Contact: Tiffany Chung, M.Phil; Phone Number: 852-35053856; Email: tiffanyc@cuhk.edu.hk

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Probability Sample

Study Population

Patients who admitted to Prince of Wales Hospital for acute stroke will be screened for eligibility.

Description

Inclusion Criteria:

• Inclusion Criteria for the Symptomatic Group:

  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, a relevant intracranial atherosclerotic stenosis ≥60%, and MES detected by TCD.
  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.

• Inclusion Criteria for the Asymptomatic Group:

  1. Patient is 30 to 85 years of age, inclusive.
  2. Patient who has a high-grade (>60%) intracranial stenosis (signal void in MR angiography) but without infarct in the corresponding vascular territory in DWI or T2-weighted sequence.
  3. Patient has no MES detected on TCD examination.
  4. Patient who has no contra-indication for the proposed imaging tests.
  5. Patient understands the purpose and requirements of the study, and has provided an informed consent.

Exclusion Criteria:

Subject who meets one or more of the following criteria cannot be recruited in the study:

1. Stroke etiology uncertain or unrelated to intracranial atherosclerosis, such as cardioembolism, Moyamoya disease, small vessel disease, etc.
2. A tandem stenosis >50% at proximal 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-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Symptomatic stroke patient; DSA and 3DRA will be performed with access through a 4F sheath at the right femoral artery. Angiograms of intracranial arteries will be obtained by contrast injection at internal carotid artery and vertebral artery ostium from a 4F H1 catheter. Each injection will contain 10ml of iopaminro 300 diluted in 1:1 with normal saline. Each angiographic run will capture a complete series of images from the arterial phase to the end of the venous phase. A 3-dimensional rotational angiogram (a scan time of 4 seconds with 120 images) will be obtained for evaluation of plaque morphology. 2. The access site will be closely observed for hemostasis after the procedure. The neurological status and renal function will be monitored. Diagnosis procedure: DSA/3DRA	Diagnostic test: DSA/3DRA; DSA/3DRA
Asymptomatic stroke patient; DSA and 3DRA will be performed with access through a 4F sheath at the right femoral artery. Angiograms of intracranial arteries will be obtained by contrast injection at internal carotid artery and vertebral artery ostium from a 4F H1 catheter. Each injection will contain 10ml of iopaminro 300 diluted in 1:1 with normal saline. Each angiographic run will capture a complete series of images from the arterial phase to the end of the venous phase. A 3-dimensional rotational angiogram (a scan time of 4 seconds with 120 images) will be obtained for evaluation of plaque morphology. 2. The access site will be closely observed for hemostasis after the procedure. The neurological status and renal function will be monitored. Diagnosis procedure: DSA/3DRA	Diagnostic test: DSA/3DRA; DSA/3DRA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The plaque morphology of high-risk IAD may be distinct from the silent ones.	The morphological attributes (surface outline, angulations and plaque volume) and collateral grading will be compared between symptomatic and asymptomatic group.	Dec, 2020

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): February 1, 2010
• Primary Completion (Anticipated): December 23, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: September 20, 2017
• First Submitted That Met QC Criteria: September 20, 2017
• First Posted (Actual): September 25, 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; Plaque morphology; DSA/3DRA
• 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. 2011.021

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