Clinical trial NCT05623943: Comparison of Cerebral Artery Pressure Gradient and Cerebral Blood Flow Measured by Arterial Spin Labeling
Official title: Comparison of Cerebral Artery Pressure Gradient and Cerebral Blood Flow Measured by Arterial Spin Labeling
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke, Ischemic
Intracranial Atherosclerosis
Keywords: Intracranial atherosclerotic diseases
Fractional Flow Reserve
intravascular pressure gradients
Cerebral blood flow
Arterial Spin Labeling
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
Collaborators: name: National Key Research and Development Project, China
First posted: 2022-11-21
Enrollment: 25
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with symptomatic ICAS resorting to endovascular therapy in our center were recruited consecutively.

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.


Eligibility criteria: Inclusion Criteria:

1. Patients aged 40 years or older.
2. 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).
3. 50% to 99% stenosis (calculated by modified WASID method) of responsible arterial occlusion, confirmed by digital subtraction angiography (DSA).
4. Informed of the study protocol and objectives.

Exclusion Criteria:

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

Primary outcomes:
measure: The relevance between intravascular pressure gradients and CBF
timeFrame: Post-operation, an average of 3 days
Secondary outcomes:
measure: The difference of ASL-CBF between pre- and post-operation
timeFrame: Baseline and Post-operation, an average of 3 days
measure: The difference of FFR between pre- and post-operation
timeFrame: Baseline and Post-operation, an average of 3 days
measure: Any stroke or death in short term.
timeFrame: 30±5 days
measure: Procedure-related complications
timeFrame: 30±5 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
state: Beijing
Study officials:
References: