Morphology of Advanced Symptomatic Cerebral Plaques With High Embolic Potential

Recruiting

• Conditions: Atheroscleroses, Cerebral; Ischemic Stroke
• Interventions: Diagnostic Test: DSA/3DRA

• Registration Number: NCT03291652
• Lead Sponsor: Chinese University of Hong Kong

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).

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 Timeline

• Study Start: 2010-02
• Study First Submitted: 2017-09-20
• Study First Submitted QC: 2017-09-20
• Study First Posted: 2017-09-25
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-05
• Last Update Posted: 2023-05-06
• Primary Completion: 2023-12-23
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Symptomatic stroke patient	DSA/3DRA	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
Asymptomatic stroke patient	DSA/3DRA	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

Primary Outcome Measures

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

Trial Locations

Locations (1)

Chinese University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong