Morphology of Advanced Symptomatic Cerebral Plaques With High Embolic Potential

Ischemic Stroke Clinical Trial

Official title:

Morphology of Advanced Symptomatic Cerebral Plaques With High Embolic Potential

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03291652
• Other study ID #: crec no. 2011.021
• Status: Recruiting
• Start date: February 2010
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2023
• Source: Chinese University of Hong Kong
• Contact: Thomas Wai Hong LEUNG, FRCP
• Phone: 852-35053593
• Email: drtleung[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: December 31, 2023
• Est. primary completion date: December 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atheroscleroses, Cerebral
• Atherosclerosis
• Intracranial Arteriosclerosis
• Ischemic Stroke

Intervention

Diagnostic Test:
• DSA/3DRA
DSA/3DRA

Locations

Country	Name	City	State
Hong Kong	Chinese University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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