Morphology of Advanced Symptomatic Cerebral Plaques With High Embolic Potential

NCT03291652 | Recruiting

• 1 other identifier: crec no. 2011.021
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ischemic Stroke; Atheroscleroses, Cerebral

Keywords

Ischemic Stroke; atherosclerosis; Plaque morphology; DSA/3DRA

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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

Interventions

DSA/3DRA DIAGNOSTIC_TEST

DSA/3DRA

Asymptomatic stroke patient; Symptomatic stroke patient

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

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, a relevant intracranial atherosclerotic stenosis ≥60%, and MES detected by TCD.
• 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.
• Patient is 30 to 85 years of age, inclusive.
• 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.
• Patient has no MES detected on TCD examination.
• 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:

• Subject who meets one or more of the following criteria cannot be recruited in the study:
• Stroke etiology uncertain or unrelated to intracranial atherosclerosis, such as cardioembolism, Moyamoya disease, small vessel disease, etc.
• A tandem stenosis \>50% at proximal 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 CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 20, 2017
• First Posted: September 25, 2017
• Study Start: February 1, 2010
• Primary Completion (Estimated): December 23, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)