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

Stroke, Ischemic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05623943
• Other study ID #: XWFFR-1
• Status: Completed
• Start date: June 1, 2019
• Est. completion date: February 1, 2023

Study information

• Verified date: November 2022
• Source: Xuanwu Hospital, Beijing
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: February 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Intracranial Arteriosclerosis
• Intracranial Atherosclerosis
• Ischemic Stroke
• Stroke, Ischemic

Intervention

Procedure:
• Endovascular treatment
Patients treated with endovascular treatment, including balloon angioplasty alone and balloon angioplasty plus stenting.

Locations

Country	Name	City	State
China	Xuanwu Hospital, Capital Medical University	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing	National Key Research and Development Project, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Any stroke or death in short term.		30±5 days
Secondary	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