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

NCT05623943 | Completed

• 1 other identifier: XWFFR-1
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Ischemic; Intracranial Atherosclerosis

Keywords

Intracranial atherosclerotic diseases; Fractional Flow Reserve; intravascular pressure gradients; Cerebral blood flow; Arterial Spin Labeling

Outcome Measures

Primary Outcomes (1)

• The relevance between intravascular pressure gradients and CBF

  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.

  Post-operation, an average of 3 days

Secondary Outcomes (4)

• The difference of ASL-CBF between pre- and post-operation

  Baseline and Post-operation, an average of 3 days

• The difference of FFR between pre- and post-operation

  Baseline and Post-operation, an average of 3 days

• Any stroke or death in short term.

  30±5 days

• Procedure-related complications

  30±5 days

Study Arms (1)

ICAS patients planning for endovascular treatment

Patients received pressure-wire-based intravascular pressure measurement and ASL measurement before and after operation.

Procedure: Endovascular treatment

Interventions

Endovascular treatment PROCEDURE

Patients treated with endovascular treatment, including balloon angioplasty alone and balloon angioplasty plus stenting.

ICAS patients planning for endovascular treatment

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with symptomatic ICAS resorting to endovascular therapy in our center were recruited consecutively.

You may qualify if:

• 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).
• % 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.

You may not qualify if:

• 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
• Patients with severe dementia or mental disorders, who cannot cooperate with examination

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead
• National Key Research and Development Project, China: collaborator

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Ischemic Stroke; Intracranial Arteriosclerosis

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Arterial Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: November 21, 2022
• Study Start: June 1, 2019
• Primary Completion: January 1, 2023
• Study Completion: February 1, 2023
• Last Updated: April 27, 2023

Record last verified: 2022-11

Locations

CN (1)