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Completed

NCT Number: NCT05623943

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.

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Key information

Conditions

Stroke, Ischemic Arterial Occlusive Diseases Arteriosclerosis Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Intracranial Arterial Diseases Intracranial Arteriosclerosis Intracranial Atherosclerosis Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).
  • 50% 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.

Exclusion criteria

  • 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

Treatment and study plan

endovascular treatment

Procedure

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

Primary outcomes

  1. The relevance between intravascular pressure gradients and CBF

    Time frame: Post-operation, an average of 3 days

    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.

Secondary outcomes

  1. The difference of ASL-CBF between pre- and post-operation

    Time frame: Baseline and Post-operation, an average of 3 days

    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.

  2. The difference of FFR between pre- and post-operation

    Time frame: Baseline and Post-operation, an average of 3 days

    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.

  3. Any stroke or death in short term.

    Time frame: 30±5 days

  4. Procedure-related complications

    Time frame: 30±5 days

    Any complications, related to manometry and treatment, will be recorded including arterial dissection, arterial perforation, acute vascular occlusion and other adverse events.

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Collaborators

  • National Key Research and Development Project, China

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Nov 21, 2022
Registry last updated
Apr 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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