Cerebral Artery StenosisHACASSNCT06058676
Prediction of Hyperperfusion After Carotid Stenting by Multi-parameter Characteristics Based on Cerebral Autoregulation
An observational study of Cerebral Artery Stenosis and Carotid Artery Stent, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
Cerebral hyperperfusion syndrome (CHS) is one of the severe complication after carotid artery stenting with a high mortality rate. CHS was defined as cerebral hyperperfusion (CH) with clinical symptoms such as unilateral headache, convulsions, hemiparesis/hemiplegia, visual disturbances, ataxia, aphasia, while CH… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cerebral Artery Stenosis, Carotid Artery Stent, Dynamic Cerebral Autoregulation
- What is being tested?
- carotid artery stenting
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to Sep 2026
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and female patients 18 years of age and older. Symptomatic patients with internal carotid artery stenosis≥50% on angiography, or asymptomatic patients with internal carotid artery stenosis≥70% on angiography.
Who may be able to join
- (1) Male and non-pregnant, non-breastfeeding female subjects whose age is ≥ 18 years and ≤ 80.
- Symptomatic patients with internal carotid artery stenosis≥50% on angiography, or asymptomatic patients with internal carotid artery stenosis≥70% on angiography treatable with carotid artery stenting.
- Patient is willing and capable of complying with all study protocol requirements, including the specified follow-up visits and can be contacted by telephone.
Who cannot join
- (1) Patients with severe carotid artery stenosis caused by non-atherosclerosis diseases, such as dissection or arteritis.
- Inability to cooperate with all this examination.
- Patients without complete clinical or imaging information.
- Patients not evaluated by CDU before CAS or within 1 week after CAS.
- Lack of follow up with CDU after CAS.
- Patients with poor temporal sound window or closure of the temporal window.
- Hyperthyroidism, hemicrania, severe arrhythmia and other diseases affecting dCA.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Vascular Ultrasonography, Xuanwu Hospital of Capital Medical University
Beijing, Beijing Municipality, 100053
About this study
Official title: A Controlled Clinical Study of Prediction of Cerebral Hyperperfusion Syndrome After Carotid Artery Stenting by Using Multi-parameter Characteristics Based on Cerebral Autoregulation
Cerebral hyperperfusion syndrome (CHS) is one of the severe complication after carotid artery stenting with a high mortality rate. CHS was defined as cerebral hyperperfusion (CH) with clinical symptoms such as unilateral headache, convulsions, hemiparesis/hemiplegia, visual disturbances, ataxia, aphasia, while CH could be a disastrous outcome causing complication after carotid revascularization if not managed properly and timely.
This is a single-center prospective cohort study to investigate the risks of CH after carotid artery stenting. All patients with severe carotid artery stenosis underwent carotid arterial ultrasonography and dynamic cerebral autoregulation (dCA) test by transcranial Doppler sonography (TCD) before operation. The postoperative carotid ultrasound and transcranial Doppler sonography (TCD) results are also needed. The investigators will collect this test data at 48h, 1 month and 3months after carotid artery stenting（CAS）. According to the examination results, they were divided into two groups: CH group and non-CH group.
Read more
The investigators will collect data before CAS, on all participants' age, sex, heart rate, BP and end-tidal carbon dioxide (ET-CO2) and the following information from the patients : (i)demographic data, such as hypertension, coronary heart disease, diabetes, hyperlipidemia, smoking and body mass index; (ii) relevant clinical symptoms; (iii) preoperative colour Doppler ultrasonography（CDU）and transcranial Doppler sonography(TCD) results; (iv) The cerebral blood flow velocity (CBFV) of the middle cerebral artery（MCA） induced will be measured by non-invasively and continuously dCA test.
This study could be aimed to analyze the factors influencing cerebral hyperperfusion after CAS. The purpose of this study will be to perform more precise risk stratification for high-risk CH patients and improve the quality of life of them.
Statistical Analysis The Statistical Package for the Social Sciences（SPSS）software Version 26.0 (IBM, New York, USA) will be used for statistical analyses. The indicators with P < 0.2 in the univariate analysis will be entered into a logistic regression analysis to investigate the independent risk factors for CH after CAS. All tests will be performed two sided, and a P < 0.05 will be considered statistically significant.
Read the detailed description
- To analysis the incidence of postoperative complications such as CH and CHS within 1 months and to find the risk factors of CH.
- To enroll 400 cases of patients suffering from carotid artery stenosis. the investigators perform TCD on patients by Sonographer for identifying CH.
- Postoperative CH will be defined in patients whose MCA mean velocity increased by more than 100% within 48 hour after carotid artery stent.
- CH and CHS mostly occurs within one week after CAS. Although there are a few reports of CHS occurring from three weeks to four weeks after CAS.
- All tests are non-invasive.
- The diagnosis of CHS will be based on the following criteria:
- The appearance of symptoms within 1 month after surgery.
- First-time unilateral headache, convulsions, hemiparesis/hemiplegia, visual disturbances, ataxia, aphasia, signs of cerebral edema or intracerebral hemorrhage.
- Increase in cerebral blood flow in the middle cerebral artery > 100% compared to the preoperative value measured by transcranial dopplerography.
- Hypertensive encephalopathy, reversible posterior leukoencephalopathy syndrome and reversible cerebral vasoconstriction syndrome are excluded.
- The parameter of ultrasonic measurement
- The CDU before CAS about plaque imaging and other parameters will be stored in Statistical Package for the Social Sciences （PACS）and analyzed later.
B.The TCD peri-CAS will be used to detect main intracranial arteries, the peak systolic velocity（PSV）, end-diastolic velocity（EDV）and PI of bilateral MCA will be recorded.
C.The post-CAS imaging and parameters included the characteristics of stent and hemodynamic parameters by CDU and TCD.
- Being tested
- carotid artery stenting
- Keywords
- Ultrasonography, Carotid artery stent, Dynamic cerebral autoregulation, Cerebral hyperperfusion, Hemodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carotid artery stentingProcedure or surgery
The procedures will be performed for patients with general or local anesthesia. Implantation of stents at the site of carotid artery stenosis for the treatment of carotid severe stenosis. A suitable balloon will be selected based on the internal carotid arterial（ICA）diameter, as shown on the digital subtraction angiography（DSA）image. The use of a balloon for predilatation or postdilatation depends on the degree of stenosis. The type of stent will be selected according to several factors, such as the length and configuration of the lesion, vascular morphology, vessel diameter, plaque characteristics, stent characteristics, and surgeon experience.
| Study group | Role | What they receive |
|---|---|---|
| Patients with reduced cerebrovascular reserve | Interventions:
Procedure: carotid artery stenting Receives: Procedure: carotid artery stenting | |
| Patients with sufficient cerebrovascular reserve | Interventions:
Procedure: carotid artery stenting Receives: Procedure: carotid artery stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral hyperperfusion
Postoperative CH will be defined in patients whose MCA mean velocity increased by more than 100% after carotid artery stent.
Measured: within 7 days post-operation
Secondary outcomes (2)
Cerebral hyperperfusion syndrome
CHS always occurs after CAS of high-grade carotid artery stenosis causing cerebral hemodynamic insufficience. CHS was defined as a clinical triad of ipsilateral head ache, seizures, and neurologic deficits in the absence of cerebral ischemia after a successful carotid stenting.
Measured: with 1 month post-operation
Major stroke
The incidence of major stroke after CAS, defined as new onset of neurological symptoms causing an increase of NIHSS ≥ 4 or worsening of existing focal neurological deficit lasting ≥ 24 hours.
Measured: within 7 days post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start1 Sep 2023
- Primary completionDec 2025 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cerebral Artery StenosisStudies 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- yingqi Xing, MD, Principal investigator, Department of Vascular Ultrasonography, Xuanwu Hospital. Beijing Institute of Brain Disorders.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06058676
- Sponsor's protocol ID
- 2023-9-15
- Acronym
- HACASS
- Status last verified
- Sep 2023
- First submitted
- 21 Sep 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bonow RH, Young CC, Bass DI, Moore A, Levitt MR. Transcranial Doppler ultrasonography in neurological surgery and neurocritical care. Neurosurg Focus. 2019 Dec 1;47(6):E2. doi: 10.3171/2019.9.FOCUS19611.
PubMed 31786564Liu Y, Tarumi T, Liu B, Li J, Wu X, Zhang N, Hua Y. Dynamic Cerebral Autoregulation in Preclinical Atherosclerotic Cardiovascular Disease. J Stroke Cerebrovasc Dis. 2020 Jun;29(6):104810. doi: 10.1016/j.jstrokecerebrovasdis.2020.104810. Epub 2020 Apr 11.
PubMed 32291129Panerai RB, Brassard P, Burma JS, Castro P, Claassen JA, van Lieshout JJ, Liu J, Lucas SJ, Minhas JS, Mitsis GD, Nogueira RC, Ogoh S, Payne SJ, Rickards CA, Robertson AD, Rodrigues GD, Smirl JD, Simpson DM; Cerebrovascular Research Network (CARNet). Transfer function analysis of dynamic cerebral autoregulation: A CARNet white paper 2022 update. J Cereb Blood Flow Metab. 2023 Jan;43(1):3-25. doi: 10.1177/0271678X221119760. Epub 2022 Aug 12.
PubMed 35962478
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled Clinical Study of Prediction of Cerebral Hyperperfusion Syndrome After Carotid Artery Stenting by Using Multi-parameter Characteristics Based on Cerebral Autoregulation
- ClinicalTrials.gov ID
- NCT06058676
- Acronym / sponsor ID
- HACASS / 2023-9-15
- Keywords
- Ultrasonography, Carotid artery stent, Dynamic cerebral autoregulation, Cerebral hyperperfusion, Hemodynamics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 28 Sep 2023 (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.
Cerebral hyperperfusion syndrome (CHS) is one of the severe complication after carotid artery stenting with a high mortality rate. CHS was defined as cerebral hyperperfusion (CH) with clinical symptoms such as unilateral headache, convulsions, hemiparesis/hemiplegia, visual disturbances, ataxia, aphasia, while CH could be a disastrous outcome causing complication after carotid revascularization if not managed properly and timely.
This is a single-center prospective cohort study to investigate the risks of CH after carotid artery stenting. All patients with severe carotid artery stenosis underwent carotid arterial ultrasonography and dynamic cerebral autoregulation (dCA) test by transcranial Doppler sonography (TCD) before operation. The postoperative carotid ultrasound and transcranial Doppler sonography (TCD) results are also needed. The investigators will collect this test data at 48h, 1 month and 3months after carotid artery stenting（CAS）. According to the examination results, they were divided into two groups: CH group and non-CH group.
The investigators will collect data before CAS, on all participants' age, sex, heart rate, BP and end-tidal carbon dioxide (ET-CO2) and the following information from the patients : (i)demographic data, such as hypertension, coronary heart disease, diabetes, hyperlipidemia, smoking and body mass index; (ii) relevant clinical symptoms; (iii) preoperative colour Doppler ultrasonography（CDU）and transcranial Doppler sonography(TCD) results; (iv) The cerebral blood flow velocity (CBFV) of the middle cerebral artery（MCA） induced will be measured by non-invasively and continuously dCA test.
This study could be aimed to analyze the factors influencing cerebral hyperperfusion after CAS. The purpose of this study will be to perform more precise risk stratification for high-risk CH patients and improve the quality of life of them.
Statistical Analysis The Statistical Package for the Social Sciences（SPSS）software Version 26.0 (IBM, New York, USA) will be used for statistical analyses. The indicators with P < 0.2 in the univariate analysis will be entered into a logistic regression analysis to investigate the independent risk factors for CH after CAS. All tests will be performed two sided, and a P < 0.05 will be considered statistically significant.
Detailed description
- To analysis the incidence of postoperative complications such as CH and CHS within 1 months and to find the risk factors of CH.
- To enroll 400 cases of patients suffering from carotid artery stenosis. the investigators perform TCD on patients by Sonographer for identifying CH.
- Postoperative CH will be defined in patients whose MCA mean velocity increased by more than 100% within 48 hour after carotid artery stent.
- CH and CHS mostly occurs within one week after CAS. Although there are a few reports of CHS occurring from three weeks to four weeks after CAS.
- All tests are non-invasive.
- The diagnosis of CHS will be based on the following criteria:
- The appearance of symptoms within 1 month after surgery.
- First-time unilateral headache, convulsions, hemiparesis/hemiplegia, visual disturbances, ataxia, aphasia, signs of cerebral edema or intracerebral hemorrhage.
- Increase in cerebral blood flow in the middle cerebral artery > 100% compared to the preoperative value measured by transcranial dopplerography.
- Hypertensive encephalopathy, reversible posterior leukoencephalopathy syndrome and reversible cerebral vasoconstriction syndrome are excluded.
- The parameter of ultrasonic measurement
- The CDU before CAS about plaque imaging and other parameters will be stored in Statistical Package for the Social Sciences （PACS）and analyzed later.
B.The TCD peri-CAS will be used to detect main intracranial arteries, the peak systolic velocity（PSV）, end-diastolic velocity（EDV）and PI of bilateral MCA will be recorded.
C.The post-CAS imaging and parameters included the characteristics of stent and hemodynamic parameters by CDU and TCD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with reduced cerebrovascular reserve | – | Procedure: carotid artery stentingInterventions: Procedure: carotid artery stenting |
| Patients with sufficient cerebrovascular reserve | – | Procedure: carotid artery stentingInterventions: Procedure: carotid artery stenting |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female patients 18 years of age and older. Symptomatic patients with internal carotid artery stenosis≥50% on angiography, or asymptomatic patients with internal carotid artery stenosis≥70% on angiography.
Key inclusion criteria (3 listed)
- (1) Male and non-pregnant, non-breastfeeding female subjects whose age is ≥ 18 years and ≤ 80.
Key exclusion criteria (7 listed)
- (1) Patients with severe carotid artery stenosis caused by non-atherosclerosis diseases, such as dissection or arteritis.
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 |
|---|---|---|
| carotid artery stentingThe procedures will be performed for patients with general or local anesthesia. Implantation of stents at the site of carotid artery stenosis for the treatment of carotid severe stenosis. A suitable balloon will be selected based on the internal carotid arterial（ICA）diameter, as shown on the digital subtraction angiography（DSA）image. The use of a balloon for predilatation or postdilatation depends on the degree of stenosis. The type of stent will be selected according to several factors, such as the length and configuration of the lesion, vascular morphology, vessel diameter, plaque characteristics, stent characteristics, and surgeon experience. | Procedure or surgery | Patients with reduced cerebrovascular reserve, Patients with sufficient cerebrovascular reserve |
Primary outcome
Cerebral hyperperfusion
Time frame: within 7 days post-operation
Postoperative CH will be defined in patients whose MCA mean velocity increased by more than 100% after carotid artery stent.
2 secondary outcomes
Cerebral hyperperfusion syndrome
Time frame: with 1 month post-operation
Major stroke
Time frame: within 7 days post-operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Background: PubMed 31786564Bonow RH, Young CC, Bass DI, Moore A, Levitt MR. Transcranial Doppler ultrasonography in neurological surgery and neurocritical care. Neurosurg Focus. 2019 Dec 1;47(6):E2. doi: 10.3171/2019.9.FOCUS19611.
- Background: PubMed 32291129Liu Y, Tarumi T, Liu B, Li J, Wu X, Zhang N, Hua Y. Dynamic Cerebral Autoregulation in Preclinical Atherosclerotic Cardiovascular Disease. J Stroke Cerebrovasc Dis. 2020 Jun;29(6):104810. doi: 10.1016/j.jstrokecerebrovasdis.2020.104810. Epub 2020 Apr 11.
- Background: PubMed 35962478Panerai RB, Brassard P, Burma JS, Castro P, Claassen JA, van Lieshout JJ, Liu J, Lucas SJ, Minhas JS, Mitsis GD, Nogueira RC, Ogoh S, Payne SJ, Rickards CA, Robertson AD, Rodrigues GD, Smirl JD, Simpson DM; Cerebrovascular Research Network (CARNet). Transfer function analysis of dynamic cerebral autoregulation: A CARNet white paper 2022 update. J Cereb Blood Flow Metab. 2023 Jan;43(1):3-25. doi: 10.1177/0271678X221119760. Epub 2022 Aug 12.
- Individual participant dataSharing planned: No
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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.
yingqi Xing, MD principal investigator
Department of Vascular Ultrasonography, Xuanwu Hospital. Beijing Institute of Brain Disorders.
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 Cerebral Artery Stenosis and Carotid Artery Stent, 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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 28 Sep 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?
Results are not available in the source record.
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?
Cerebral hyperperfusion (time frame: within 7 days post-operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06058676, which also lists 3 linked publications.
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 28 Sep 2023.