Comparison of Cerebral Artery Pressure Gradient and Cerebral Blood Flow Measured by Arterial Spin Labeling

Xuanwu Hospital, Beijing1 site in 1 country25 target enrollmentJune 1, 2019

ConditionsStroke, Ischemic Intracranial Atherosclerosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Stroke, Ischemic
Sponsor: Xuanwu Hospital, Beijing
Enrollment: 25
Locations: 1
Primary Endpoint: The relevance between intravascular pressure gradients and CBF
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The goal of this observational study is to explore the ability of intravascular pressure gradients to identify hemodynamic disturbance in patients with intracranial atherosclerotic diseases (ICAS). The main questions that aim to answer are:

The correlation between intravascular pressure gradient and cerebral blood flow (CBF)
The threshold for intravascular pressure gradients to predict hemodynamic disturbance in ICAS

Patients will undergo intravascular pressure measurement and arterial spin labeling (ASL) for CBF during pre- and post-operation respectively.

Registry

clinicaltrials.gov

Start Date

June 1, 2019

End Date

February 1, 2023

Last Updated

3 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Xuanwu Hospital, Beijing

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients aged 40 years or older.
•Patients with transient ischemic attack (TIA) or nondisabling ischemic stroke caused by a focal ICAS lesion located in intracranial anterior circulation (vertebral artery, basilar artery or intracranial internal carotid artery and their major branches).
•50% to 99% stenosis (calculated by modified WASID method) of responsible arterial occlusion, confirmed by digital subtraction angiography (DSA).
•Informed of the study protocol and objectives.

Exclusion Criteria

•Non-atherosclerotic MCA stenosis
•Combined with moderate or severe stenosis of other extracranial and intracranial arteries
•Previous endovascular treatment or surgery for cerebrovascular diseases
•Large cerebral infarction (more than 1/2 MCA perfusion area)
•Combined with other neurological diseases, such as aneurysm, arteriovenous malformation, tumor, hydrocephalus, cerebral trauma, cerebral hemorrhage, multiple sclerosis, epilepsy and intracranial infection.
•Vascular abnormality or stunting, resulting in the impossibility of endovascular intervention
•Liver and kidney dysfunction, or severe allergy to the contrast agent
•Severe coagulation dysfunction
•Pregnancy or in the preparation for pregnancy
•Patients who cannot tolerate or do not allow MR screening, including metal implanting and claustrophobia

Outcomes

Primary Outcomes

The relevance between intravascular pressure gradients and CBF

Time Frame: Post-operation, an average of 3 days

Patients will be divided into 2 groups according to whether they have hemodynamic disorders before operation and improve after operation. Fractional flow reserve (FFR) measurement will be analyzed in each group.

Secondary Outcomes

Any stroke or death in short term.(30±5 days)
The difference of FFR between pre- and post-operation(Baseline and Post-operation, an average of 3 days)
The difference of ASL-CBF between pre- and post-operation(Baseline and Post-operation, an average of 3 days)
Procedure-related complications(30±5 days)