StrokeNCT03786666
Ultrasound Evaluation of Carotid Artery Atherosclerotic Plaques and Recanalization
An observational study of Stroke, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
The purpose of this multiple-center study are: 1) To establish the ultrasound criteria for evaluating vulnerable plaques by comparing the plaque echo characteristics before CEA (carotid artery endarterectomy) and plaque specimen after CEA. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- Carotid artery recanalization CEA or carotid artery stenting
- Type of treatment
- Surgery or procedure
- How many people
- 1,213 participants
- Where
- 1 siteChina
- Study dates
- 16 May 2019to 30 Dec 2020
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with carotid artery moderate (50-69%), severe (70-99%) stenosis or occlusion, who needs recanalization by CEA or stenting.
Who may be able to join
- 1) Patients with carotid artery moderate (50-69%, with symptoms), severe (70-99%, with or without symptoms) stenosis or occlusion diagnosed by CDFI and confirmed by CTA or DSA.
- 2) Patient has the indications for carotid artery stenting or CEA according to the guidelines published by the Stroke Prevention Engineering Committee, the National Health Commission of China.
- 3) Patient with complete imaging evaluation and can be followed up to at least 1 year.
Who cannot join
- 1) Patients with non-atherosclerotic carotid artery stenosis or occlusion, such as dissection, aneurysm, arteritis, cardiac embolism and et al.
- 2) Patients with cerebral hemorrhage. 3) Pregnant
Trial locations and contacts
1 site in 1 country.
China1 site
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100053
About this study
Official title: Vascular Ultrasound Evaluation of Atherosclerotic Plaques and the Success of Recanalization in Patients With Carotid Artery Stenosis and Occlusion
The purpose of this multiple-center study are: 1) To establish the ultrasound criteria for evaluating vulnerable plaques by comparing the plaque echo characteristics before CEA (carotid artery endarterectomy) and plaque specimen after CEA.
- To establish the carotid artery recanalization strategies based on the evaluation results of carotid artery and intracranial artery by color doppler flow imaging and TCCS/TCD (transcranial color coded sonography/transcranial doppler).
- To compare the success rate and the incidence of restenosis between CEA and carotid artery stenting.
Read the detailed description
In this study, a total of 1000-1200 patients with carotid artery moderate (50-69%, with symptoms), severe (70-99%) stenosis (with or without symptoms) or occlusion who received either CEA or stenting are to recruited. Before carotid artery recanalization, CDFI (color duplex flow imaging) and TCCS/TCD are used to evaluate the structures and hemodynamic of carotid artery and intracranial artery. In addition, patients are to be followed up by ultrasound 1 week, 3 month, 6month and 1 year after recanalization.
- Ultrasound examinations procedures: According to the guidelines of vascular ultrasonography published by the Stroke Prevention Engineering Committee, the National Health Commission of China in 2015. The plaque characteristics, stenosis degrees of carotid artery and intracranial arteries, and collateral circulation are evaluated by CDFI and TCCS/TCD.
- Radiology examination procedures: Before recanalization, enrolled patients receive MRI examinations to determine the presence and the location of cerebral infarction. If necessary, patients receive CT angiography (CTA) , MRI angiography (MRA) or Digital subtraction angiography (DSA) to confirm the degrees of vessel stenosis and occlusion. One week after recanalization, CT and MRI are used to identify the cerebral hemorrhage and newly cerebral infarction.
- The data collected in this study including:
- The general information of enrolled subjects, which include age, gender, resident address and telephone number, the history of hypertension, coronary artery diseases, dyslipidemia, diabetes mellitus and smoking.
- The primary endpoints are: The combination endpoints events of death, cerebral hemorrhage , newly cerebral infarction, hyperperfusion syndrome, residual sternosis≥50% within 30-day after recanalization. The secondary endpoints are the re-current cerebral artery events and the occurence of restenosis during the at least 1 year follow-up period.
- Statistical analysis plans: The Statistical Package of Social Sciences (SPSS version 22.0) software are used for statistical analysis.
- Diagnostic test are used to test the sensitivity, specificity and accuracy of ultrasound for evaluating vulnerable plaque by using plaque specimen after CEA as the "gold" standard.
- The Chi-square test are used to compare the success rate of stenting and CEA. The Cox regression analysis are used to compare the restenosis rate of stenting and CEA.
- A P<0.05 was considered statistically significance. 5. Quality assurance plan:
- The medical centers implement the projects are the stroke center awarded by the Stroke Prevention Engineering Committee, the National Health Commission of China. The medical centers have the instruments required in this study.
- Neurologists, neurosurgeons and vascular ultrasound physicians have received standard training hosted by the Stroke Prevention Engineering Committee, the National Health Commission of China and obtained excellent records.
- All the centers conduct the project followed the uniform implementation plans and each center guarantee the data input in time and accurately.
- The project has the unique database and data input in uniform format.
- There are specific staffs to check the accuracy and completeness of data.
- Conditions
- Stroke
- Being tested
- Carotid artery recanalization CEA or carotid artery stenting
- Keywords
- Stroke, Ischemia, Carotid artery Stenosis, CEA, Stenting, Ultrasound, Vulnerable plaque
- Medical subject headings
- Stroke, Ischemia, Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotid artery recanalization CEA or carotid artery stentingProcedure or surgery
Carotid artery recanalization CEA or carotid artery stenting
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of combination endpoints events including death, cerebral hemorrhage , newly cerebral infarction, hyperperfusion syndrome,and residual sternosis≥50%.
The rate of combination endpoints events, including death, cerebral hemorrhage , newly cerebral infarction, hyperperfusion syndrome, and residual sternosis≥50%
Measured: within 30-day after recanalization.
Secondary outcomes (1)
the rate of re-current cerebral artery events and the occurence of restenosis
the rate of re-current cerebral artery events and the occurence of restenosis
Measured: during the at least 1 year follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2018
- Study start16 May 2019
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- 1,213 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Soochow University, The First Hospital of Jilin University, The First Affiliated Hospital of Shanxi Medical University, The Second People's Hospital of Liaocheng, Liaocheng Brains Hospital, Lanzhou University Second Hospital, First Hospital of China Medical University, Dalian Municipal Central Hospital, Peking University Third Hospital, The Affiliated Hospital of Inner Mongolia Medical University, Henan Provincial People's Hospital, Shengli Oilfield Hospital, Zhengzhou First People's Hospital, Weihai Municipal Hospital
- Responsible party
- Sponsor
- Investigators
- Yang Hua, MD, Principal investigator, No.45 Changchun Road, Beijing,100053, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03786666
- Sponsor's protocol ID
- VUS-CAS
- Status last verified
- Mar 2023
- First submitted
- 20 Dec 2018
- Last updated
- 17 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Ultrasound Evaluation of Atherosclerotic Plaques and the Success of Recanalization in Patients With Carotid Artery Stenosis and Occlusion
- ClinicalTrials.gov ID
- NCT03786666
- Acronym / sponsor ID
- VUS-CAS
- Conditions
- Stroke
- Keywords
- Stroke, Ischemia, Carotid artery Stenosis, CEA, Stenting, Ultrasound, Vulnerable plaque
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,213 participants (actual)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Soochow University, The First Hospital of Jilin University, The First Affiliated Hospital of Shanxi Medical University, The Second People's Hospital of Liaocheng, Liaocheng Brains Hospital, Lanzhou University Second Hospital, First Hospital of China Medical University, Dalian Municipal Central Hospital, Peking University Third Hospital, The Affiliated Hospital of Inner Mongolia Medical University, Henan Provincial People's Hospital, Shengli Oilfield Hospital, Zhengzhou First People's Hospital, Weihai Municipal Hospital
- Study start
- 16 May 2019 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 26 Dec 2018 (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 purpose of this multiple-center study are: 1) To establish the ultrasound criteria for evaluating vulnerable plaques by comparing the plaque echo characteristics before CEA (carotid artery endarterectomy) and plaque specimen after CEA.
- To establish the carotid artery recanalization strategies based on the evaluation results of carotid artery and intracranial artery by color doppler flow imaging and TCCS/TCD (transcranial color coded sonography/transcranial doppler).
- To compare the success rate and the incidence of restenosis between CEA and carotid artery stenting.
Detailed description
In this study, a total of 1000-1200 patients with carotid artery moderate (50-69%, with symptoms), severe (70-99%) stenosis (with or without symptoms) or occlusion who received either CEA or stenting are to recruited. Before carotid artery recanalization, CDFI (color duplex flow imaging) and TCCS/TCD are used to evaluate the structures and hemodynamic of carotid artery and intracranial artery. In addition, patients are to be followed up by ultrasound 1 week, 3 month, 6month and 1 year after recanalization.
- Ultrasound examinations procedures: According to the guidelines of vascular ultrasonography published by the Stroke Prevention Engineering Committee, the National Health Commission of China in 2015. The plaque characteristics, stenosis degrees of carotid artery and intracranial arteries, and collateral circulation are evaluated by CDFI and TCCS/TCD.
- Radiology examination procedures: Before recanalization, enrolled patients receive MRI examinations to determine the presence and the location of cerebral infarction. If necessary, patients receive CT angiography (CTA) , MRI angiography (MRA) or Digital subtraction angiography (DSA) to confirm the degrees of vessel stenosis and occlusion. One week after recanalization, CT and MRI are used to identify the cerebral hemorrhage and newly cerebral infarction.
- The data collected in this study including:
- The general information of enrolled subjects, which include age, gender, resident address and telephone number, the history of hypertension, coronary artery diseases, dyslipidemia, diabetes mellitus and smoking.
- The primary endpoints are: The combination endpoints events of death, cerebral hemorrhage , newly cerebral infarction, hyperperfusion syndrome, residual sternosis≥50% within 30-day after recanalization. The secondary endpoints are the re-current cerebral artery events and the occurence of restenosis during the at least 1 year follow-up period.
- Statistical analysis plans: The Statistical Package of Social Sciences (SPSS version 22.0) software are used for statistical analysis.
- Diagnostic test are used to test the sensitivity, specificity and accuracy of ultrasound for evaluating vulnerable plaque by using plaque specimen after CEA as the "gold" standard.
- The Chi-square test are used to compare the success rate of stenting and CEA. The Cox regression analysis are used to compare the restenosis rate of stenting and CEA.
- A P<0.05 was considered statistically significance. 5. Quality assurance plan:
- The medical centers implement the projects are the stroke center awarded by the Stroke Prevention Engineering Committee, the National Health Commission of China. The medical centers have the instruments required in this study.
- Neurologists, neurosurgeons and vascular ultrasound physicians have received standard training hosted by the Stroke Prevention Engineering Committee, the National Health Commission of China and obtained excellent records.
- All the centers conduct the project followed the uniform implementation plans and each center guarantee the data input in time and accurately.
- The project has the unique database and data input in uniform format.
- There are specific staffs to check the accuracy and completeness of data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with carotid artery moderate (50-69%), severe (70-99%) stenosis or occlusion, who needs recanalization by CEA or stenting.
Key inclusion criteria (3 listed)
- 1) Patients with carotid artery moderate (50-69%, with symptoms), severe (70-99%, with or without symptoms) stenosis or occlusion diagnosed by CDFI and confirmed by CTA or DSA.
- 2) Patient has the indications for carotid artery stenting or CEA according to the guidelines published by the Stroke Prevention Engineering Committee, the National Health Commission of China.
- 3) Patient with complete imaging evaluation and can be followed up to at least 1 year.
Key exclusion criteria (2 listed)
- 1) Patients with non-atherosclerotic carotid artery stenosis or occlusion, such as dissection, aneurysm, arteritis, cardiac embolism and et al.
- 2) Patients with cerebral hemorrhage. 3) Pregnant
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 recanalization CEA or carotid artery stentingCarotid artery recanalization CEA or carotid artery stenting | Procedure or surgery | – |
Primary outcome
The rate of combination endpoints events including death, cerebral hemorrhage , newly cerebral infarction, hyperperfusion syndrome,and residual sternosis≥50%.
Time frame: within 30-day after recanalization.
The rate of combination endpoints events, including death, cerebral hemorrhage , newly cerebral infarction, hyperperfusion syndrome, and residual sternosis≥50%
1 secondary outcome
the rate of re-current cerebral artery events and the occurence of restenosis
Time frame: during the at least 1 year follow-up period
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 17 Mar 2023.
- 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.
Yang Hua, MD principal investigator
No.45 Changchun Road, Beijing,100053, China
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, 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 2 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 17 Mar 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 rate of combination endpoints events including death, cerebral hemorrhage , newly cerebral infarction, hyperperfusion syndrome,and residual sternosis≥50%. (time frame: within 30-day after recanalization.). 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 17 Mar 2023.