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

NCT ID: NCT05623943

Last Updated: 2023-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-01

Study Completion Date

2023-02-01

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke, Ischemic Intracranial Atherosclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ICAS patients planning for endovascular treatment

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

Endovascular treatment

Intervention Type PROCEDURE

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

Interventions

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Endovascular treatment

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Key Research and Development Project, China

UNKNOWN

Sponsor Role collaborator

Xuanwu Hospital, Beijing

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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XWFFR-1

Identifier Type: -

Identifier Source: org_study_id

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