Stroke, IschemicNCT05623943
Comparison of Cerebral Artery Pressure Gradient and Cerebral Blood Flow Measured by Arterial Spin Labeling
An observational study of Stroke, Ischemic and Intracranial Atherosclerosis, run by Xuanwu Hospital, Beijing at 1 site in China.
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). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Stroke, Ischemic, Intracranial Atherosclerosis
- What is being tested?
- Endovascular treatment
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2019to 1 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with symptomatic ICAS resorting to endovascular therapy in our center were recruited consecutively.
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality
About this study
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.
- Conditions
- Stroke, Ischemic, Intracranial Atherosclerosis
- Being tested
- Endovascular treatment
- Keywords
- Intracranial atherosclerotic diseases, Fractional Flow Reserve, intravascular pressure gradients, Cerebral blood flow, Arterial Spin Labeling
- Medical subject headings
- Ischemic Stroke, Intracranial Arteriosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular treatmentProcedure or surgery
Patients treated with endovascular treatment, including balloon angioplasty alone and balloon angioplasty plus stenting.
| Study group | Role | What they receive |
|---|---|---|
| ICAS patients planning for endovascular treatment | Patients received pressure-wire-based intravascular pressure measurement and ASL measurement before and after operation. Receives: Procedure: Endovascular treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post-operation, an average of 3 days
Secondary outcomes (4)
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.
Measured: 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.
Measured: Baseline and Post-operation, an average of 3 days
Any stroke or death in short term.
Measured: 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.
Measured: 30±5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2022
- Study start1 Jun 2019
- Primary completion1 Jan 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- National Key Research and Development Program of China
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05623943
- Sponsor's protocol ID
- XWFFR-1
- Status last verified
- Nov 2022
- First submitted
- 28 Oct 2022
- Last updated
- 27 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Cerebral Artery Pressure Gradient and Cerebral Blood Flow Measured by Arterial Spin Labeling
- ClinicalTrials.gov ID
- NCT05623943
- Acronym / sponsor ID
- XWFFR-1
- Conditions
- Stroke, Ischemic, Intracranial Atherosclerosis
- Keywords
- Intracranial atherosclerotic diseases, Fractional Flow Reserve, intravascular pressure gradients, Cerebral blood flow, Arterial Spin Labeling
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Collaborators
- National Key Research and Development Program of China
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 21 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICAS patients planning for endovascular treatment | – | Procedure: Endovascular treatmentPatients received pressure-wire-based intravascular pressure measurement and ASL measurement before and after operation. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with symptomatic ICAS resorting to endovascular therapy in our center were recruited consecutively.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endovascular treatmentPatients treated with endovascular treatment, including balloon angioplasty alone and balloon angioplasty plus stenting. | Procedure or surgery | ICAS patients planning for endovascular treatment |
Primary outcome
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.
4 secondary outcomes
The difference of ASL-CBF between pre- and post-operation
Time frame: Baseline and Post-operation, an average of 3 days
The difference of FFR between pre- and post-operation
Time frame: Baseline and Post-operation, an average of 3 days
Any stroke or death in short term.
Time frame: 30±5 days
Procedure-related complications
Time frame: 30±5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Ischemic and Intracranial Atherosclerosis, run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The relevance between intravascular pressure gradients and CBF (time frame: Post-operation, an average of 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2023.