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

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.

Study Overview

• Status: Completed
• Conditions: Stroke, Ischemic; Intracranial Atherosclerosis
• Intervention / Treatment: Procedure: Endovascular treatment

• Study Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

• Study Contact: Name: Long Li; Phone Number: +8618610402680; Email: lilong3516@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Xuanwu Hospital, Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ICAS patients planning for endovascular treatment; Patients received pressure-wire-based intravascular pressure measurement and ASL measurement before and after operation.	Procedure: Endovascular treatment; Patients treated with endovascular treatment, including balloon angioplasty alone and balloon angioplasty plus stenting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The difference of ASL-CBF between pre- and post-operation	The mean cerebral blood flow (CBF) of ipsilateral region of interest (ROI) in two different layers will be recorded as CBF in MCA perfusion area of this side. Relative CBF (rCBF) is defined as the ratio of the affected side CBF to the contralateral CBF. When preoperative rCBF<0.9 and postoperative rCBF≥0.9, the patient will be considered to have hemodynamic disorders and be improved post-operation.	Baseline and Post-operation, an average of 3 days
The difference of FFR between pre- and post-operation	FFR measurement will be performed at rest by 0.014-inch pressure guide wires (C12008, Abbot St. Jude Medical, Minneapolis, MN, USA) designed for coronary diseases. The mean endovascular pressure of distal and proximal lesions will be measured and recorded as Pd and Pa, respectively. Pd/Pa and Pa-Pd will be calculated and recorded before and after endovascular treatment.	Baseline and Post-operation, an average of 3 days
Any stroke or death in short term.		30±5 days
Procedure-related complications	Any complications, related to manometry and treatment, will be recorded including arterial dissection, arterial perforation, acute vascular occlusion and other adverse events.	30±5 days

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing
• Collaborators: National Key Research and Development Project, China

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Actual): January 1, 2023
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: October 28, 2022
• First Submitted That Met QC Criteria: November 13, 2022
• First Posted (Actual): November 21, 2022

Study Record Updates

• Last Update Posted (Actual): April 27, 2023
• Last Update Submitted That Met QC Criteria: April 25, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Fractional Flow Reserve; Cerebral blood flow; Intracranial atherosclerotic diseases; intravascular pressure gradients; Arterial Spin Labeling
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Stroke; Intracranial Arterial Diseases; Ischemic Stroke; Atherosclerosis; Intracranial Arteriosclerosis
• Other Study ID Numbers: XWFFR-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No