Morphology of Advanced Symptomatic Cerebral Plaques With High Embolic Potential

The Chinese University of Hong Kong

Status: Enrolling

Conditions: Ischemic Stroke; Atheroscleroses, Cerebral

Treatments: Diagnostic Test: DSA/3DRA

Study type: Observational

Funder types: Other

Identifiers

NCT03291652

crec no. 2011.021

Details and patient eligibility

About

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

Full 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 30 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

140 participants in 2 patient groups

Symptomatic stroke patient

Description:

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

Treatment:

Diagnostic Test: DSA/3DRA

Asymptomatic stroke patient

Description:

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

Treatment:

Diagnostic Test: DSA/3DRA