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

Sponsor
Xuanwu Hospital, Beijing (Other)
Overall Status
Recruiting
CT.gov ID
NCT05623943
Collaborator
National Key Research and Development Project, China (Other)
25
1
43
0.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Endovascular treatment

Study Design

Study Type:
Observational
Anticipated Enrollment :
25 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Comparison of Cerebral Artery Pressure Gradient and Cerebral Blood Flow Measured by Arterial Spin Labeling
Actual Study Start Date :
Jun 1, 2019
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. The relevance between intravascular pressure gradients and CBF [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 Outcome Measures

  1. The difference of ASL-CBF between pre- and post-operation [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 [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. [30±5 days]

  4. Procedure-related complications [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Xuanwu Hospital, Capital Medical University Beijing Beijing China

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Xuanwu Hospital, Beijing
ClinicalTrials.gov Identifier:
NCT05623943
Other Study ID Numbers:
  • XWFFR-1
First Posted:
Nov 21, 2022
Last Update Posted:
Nov 21, 2022
Last Verified:
Nov 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Xuanwu Hospital, Beijing
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 21, 2022